Oral products

ABSTRACT

A composition configured for oral use is provided, the composition including a filler in an amount of at least 20% by weight, based on the total weight of the composition, and at least one active ingredient including one or more botanical materials, stimulants, amino acids, vitamins, antioxidants, cannabinoids, pharmaceutical agents, or a combination thereof. The composition further includes a salt and at least one sweetener. The composition has a moisture content of at least about 40% by weight, based on the total weight of the composition.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is continuation of International Application No.PCT/IB2020/061476, filed Dec. 4, 2020, which is a continuation-in-partof U.S. patent application Ser. No. 16/707,117, filed on Dec. 9, 2019;and claims priority to U.S. Provisional Application No. 63/036,248,filed on Jun. 8, 2020, which are incorporated herein by reference intheir entirety and for all purposes.

FIELD OF THE DISCLOSURE

The present disclosure relates to compositions intended for human use.The compositions are configured for oral use and deliver substances suchas flavors and/or active ingredients during use. Such products mayinclude tobacco or a product derived from tobacco, or may betobacco-free alternatives.

BACKGROUND

Tobacco may be enjoyed in a so-called “smokeless” form. Particularlypopular smokeless tobacco products are employed by inserting some formof processed tobacco or tobacco-containing formulation into the mouth ofthe user. Conventional formats for such smokeless tobacco productsinclude moist snuff, snus, and chewing tobacco, which are typicallyformed almost entirely of particulate, granular, or shredded tobacco,and which are either portioned by the user or presented to the user inindividual portions, such as in single-use pouches or sachets. Othertraditional forms of smokeless products include compressed oragglomerated forms, such as plugs, tablets, or pellets. Alternativeproduct formats, such as tobacco-containing gums and mixtures of tobaccowith other plant materials, are also known. See for example, the typesof smokeless tobacco formulations, ingredients, and processingmethodologies set forth in U.S. Pat. Nos. 1,376,586 to Schwartz;4,513,756 to Pittman et al.; 4,528,993 to Sensabaugh, Jr. et al.;4,624,269 to Story et al.; 4,991,599 to Tibbetts; 4,987,907 to Townsend;5,092,352 to Sprinkle, III et al.; 5,387,416 to White et al.; 6,668,839to Williams; 6,834,654 to Williams; 6,953,040 to Atchley et al.;7,032,601 to Atchley et al.; and 7,694,686 to Atchley et al.; U.S. Pat.Pub. Nos. 2004/0020503 to Williams; 2005/0115580 to Quinter et al.;2006/0191548 to Strickland et al.; 2007/0062549 to Holton, Jr. et al.;2007/0186941 to Holton, Jr. et al.; 2007/0186942 to Strickland et al.;2008/0029110 to Dube et al.; 2008/0029116 to Robinson et al.;2008/0173317 to Robinson et al.; 2008/0209586 to Neilsen et al.;2009/0065013 to Essen et al.; and 2010/0282267 to Atchley, as well asWO2004/095959 to Arnarp et al., each of which is incorporated herein byreference.

Smokeless tobacco product configurations that combine tobacco materialwith various binders and fillers have been proposed more recently, withexample product formats including lozenges, pastilles, gels, extrudedforms, and the like. See, for example, the types of products describedin US Patent App. Pub. Nos. 2008/0196730 to Engstrom et al.;2008/0305216 to Crawford et al.; 2009/0293889 to Kumar et al.;2010/0291245 to Gao et al; 2011/0139164 to Mua et al.; 20 2/0037175 toCantrell et al.; 2012/0055494 to Hunt et al.; 2012/0138073 to Cantrellet al.; 2012/0138074 to Cantrell et al.; 2013/0074855 to Holton, Jr.;2013/0074856 to Holton, Jr.; 2013/0152953 to Mua et al.; 2013/0274296 toJackson et al.; 2015/0068545 to Moldoveanu et al.; 2015/0101627 toMarshall et al.; and 2015/0230515 to Lampe et al., each of which isincorporated herein by reference.

BRIEF SUMMARY

The present disclosure generally provides product compositionsconfigured for oral use, the product compositions comprising a filler,at least one active ingredient, a salt, and at least one sweetener. Theproduct composition has a moisture content of at least about 40% byweight, based on the total weight of the composition.

Accordingly, in one aspect, the disclosure provides a compositioncomprising a filler in an amount of at least 20% by weight, based on thetotal weight of the composition; at least one active ingredientcomprising one or more botanical materials, stimulants, amino acids,vitamins, antioxidants, cannabinoids, pharmaceutical agents, or acombination thereof; a salt; and at least one sweetener; wherein thecomposition has a moisture content of at least about 40% by weight,based on the total weight of the composition.

In some embodiments, the filler is microcrystalline cellulose.

In some embodiments, the composition further comprises a cellulosederivative.

In some embodiments, the salt is sodium chloride, ammonium chloride, ora combination thereof.

In some embodiments, the composition further comprises a taste modifier.In some embodiments, the taste modifier modifies one or more of bitter,sweet, salty, or sour tastes. In some embodiments, the taste modifier isselected from the group consisting of gamma-aminobutryic acid (GABA),adenosine monophosphate (AMP), lactisole, a vanilloid receptor agonist,an analgesic or anesthetic herb, menthol, eucalyptus, mint, andcinnamon. In some embodiments, the taste modifier is capsaicin.

In some embodiments, the active ingredient is a botanical material. Insome embodiments, the botanical material is Korean ginseng.

In some embodiments, the active ingredient is a stimulant. In someembodiments, the stimulant is caffeine, theanine, or a combinationthereof.

In some embodiments, the composition further comprises a vitamin as anadditional active ingredient. In some embodiments, the vitamin is B6,B12, or a combination thereof.

In some embodiments, the composition further comprises an amino acid asan additional active ingredient. In some embodiments, the amino acid istaurine.

In some embodiments, the composition further comprises an alginate.

In some embodiments, the active ingredient is selected from the groupconsisting of green tea, turmeric, and white mulberry, ashwagandha,baobab, chlorophyll, cordyceps, guarana, ginseng, maca, caffeine,theacrine, taurine, theanine, phenylalanine, tyrosine, tryptophan,vitamin B6, vitamin B12, vitamin E, vitamin C, GABA, vitamin C, lemonbalm extract, ginseng, citicoline, sunflower lecithin, cannabinoids,terpenes, and combinations thereof.

In some embodiments, the active ingredient is selected from the groupconsisting of caffeine, taurine, GABA, theanine, vitamin C, lemon balmextract, ginseng, citicoline, sunflower lecithin, and combinationsthereof.

In some embodiments, the active ingredient comprises a combination oftheanine and gamma-aminobutyric acid. In some embodiments, the activeingredient comprises a combination of theanine, gamma-aminobutyric acid,and optionally lemon balm extract.

In some embodiments, the active ingredient comprises a combination ofcaffeine, taurine, and Vitamin C.

In some embodiments, the active ingredient comprises a combination ofcaffeine, theanine, and optionally, ginseng. In some embodiments, theactive ingredient comprises a combination of caffeine, theanine,ginseng, and citicoline.

In some embodiments, the composition further comprises one or moreorganic acids. In some embodiments, the one or more organic acids ispresent in the composition in an amount by weight of from about 0.1 toabout 10%, based on the total weight of the composition. In someembodiments, the one or more organic acids is present in the compositionin an amount by weight of from about 0.1 to about 0.5%, based on thetotal weight of the composition. In some embodiments, the one or moreorganic acids is an alkyl carboxylic acid, an aryl carboxylic acid, or acombination of any thereof. In some embodiments, the one or more organicacids is citric acid, malic acid, tartaric acid, octanoic acid, benzoicacid, a toluic acid, salicylic acid, or a combination thereof. In someembodiments, the one or more organic acids is citric acid.

In some embodiments, the active ingredient is bleached.

In some embodiments, the composition is substantially free of tobacco.

In some embodiments, the composition comprises a nicotine component.

In some embodiments, the composition is substantially free of nicotine.

In some embodiments, the composition is enclosed in a pouch to form apouched product.

In another aspect is provided a pouched composition comprising a pouch,and a composition contained within the pouch, the compositioncomprising: a filler in an amount of at least 20% by weight, based onthe total weight of the composition; theanine, gamma-aminobutyric acid,and optionally, lemon balm extract; a salt; and at least one sweetener;wherein the composition has a moisture content of from about 30 to about40% by weight, based on the total weight of the composition.

The disclosure includes, without limitations, the following embodiments.

Embodiment 1: A composition comprising: a filler in an amount of atleast 20% by weight, based on the total weight of the composition; atleast one active ingredient comprising one or more botanical materials,stimulants, amino acids, vitamins, antioxidants, cannabinoids,pharmaceutical agents, or a combination thereof; a salt; and at leastone sweetener; wherein the composition has a moisture content of atleast about 40% by weight, based on the total weight of the composition.

Embodiment 2: The composition of embodiment 1, wherein the filler ismicrocrystalline cellulose.

Embodiment 3: The composition of any one of embodiments 1 or 2, furthercomprising a cellulose derivative.

Embodiment 4: The composition of any one of embodiments 1 to 3, whereinthe salt is sodium chloride, ammonium chloride, or a combinationthereof.

Embodiment 5: The composition of any one of embodiments 1 to 4, furthercomprising a taste modifier.

Embodiment 6: The composition of any one of embodiments 1 to 5, whereinthe taste modifier modifies one or more of bitter, sweet, salty, or sourtastes.

Embodiment 7: The composition of any one of embodiments 1 to 6, whereinthe taste modifier is selected from the group consisting ofgamma-aminobutryic acid (GABA), adenosine monophosphate (AMP),lactisole, a vanilloid receptor agonist, an analgesic or anestheticherb, menthol, eucalyptus, mint, and cinnamon.

Embodiment 8: The composition of any one of embodiments 1 to 7, whereinthe taste modifier is capsaicin.

Embodiment 9: The composition of any one of embodiments 1 to 8, whereinthe active ingredient is a botanical material.

Embodiment 10: The composition of any one of embodiments 1 to 9, whereinthe botanical material is Korean ginseng.

Embodiment 11: The composition of any one of embodiments 1 to 10,wherein the active ingredient is a stimulant.

Embodiment 12: The composition of any one of embodiments 1 to 11,wherein the stimulant is caffeine, theanine, or a combination thereof.

Embodiment 13: The composition of any one of embodiments 1 to 12,further comprising a vitamin as an additional active ingredient.

Embodiment 14: The composition of any one of embodiments 1 to 13,wherein the vitamin is B6, B12, or a combination thereof.

Embodiment 15: The composition of any one of embodiments 1 to 14,further comprising an amino acid as an additional active ingredient.

Embodiment 16: The composition of any one of embodiments 1 to 15,further comprising an alginate.

Embodiment 17: The composition of any one of embodiments 1 to 16,wherein the amino acid is taurine.

Embodiment 18: The composition of any one of embodiments 1 to 15,wherein the active ingredient comprises a combination of theanine andgamma-aminobutyric acid.

Embodiment 19: The composition of any one of embodiments 1 to 18,further comprising lemon balm extract.

Embodiment 20: The composition of any one of embodiments 1 to 16,wherein the active ingredient comprises a combination of caffeine,taurine, and Vitamin C.

Embodiment 21: The composition of any one of embodiments 1 to 16,wherein the active ingredient comprises a combination of caffeine,theanine, and ginseng, and optionally, citicoline.

Embodiment 22: The composition of any one of embodiments 1 to 21,further comprising one or more organic acids.

Embodiment 23: The composition of any one of embodiments 1 to 22,wherein the one or more organic acids is present in the composition inan amount by weight of from about 0.1 to about 10%, based on the totalweight of the composition.

Embodiment 24: The composition of any one of embodiments 1 to 23,wherein the one or more organic acids is present in the composition inan amount by weight of from about 0.1 to about 0.5%, based on the totalweight of the composition.

Embodiment 25: The composition of any one of embodiments 1 to 24,wherein the one or more organic acids is an alkyl carboxylic acid, anaryl carboxylic acid, or a combination of any thereof.

Embodiment 26: The composition of any one of embodiments 1 to 25,wherein the one or more organic acids is citric acid, malic acid,tartaric acid, octanoic acid, benzoic acid, a toluic acid, salicylicacid, or a combination thereof.

Embodiment 27: The composition of any one of embodiments 1 to 26,wherein the one or more organic acids is citric acid.

Embodiment 28: The composition of any one of embodiments 1 to 27,wherein the salt is sodium chloride, ammonium chloride, or a combinationthereof.

Embodiment 29: The composition of any one of embodiments 1 to 28,wherein the composition is substantially free of tobacco.

Embodiment 30: The composition of any one of embodiments 1 to 29,wherein the composition is substantially free of nicotine.

Embodiment 31: The composition of any one of embodiments 1 to 30,wherein the active ingredient is bleached.

Embodiment 32: The composition of any one of embodiments 1 to 31,further comprising a flavoring agent.

Embodiment 33: The composition of any one of embodiments 1 to 32,wherein the composition is enclosed in a pouch to form a pouchedproduct.

Embodiment 34: The composition of any one of embodiments 1 to 33,comprising ashwagandha.

Embodiment 35: The composition of any one of embodiments 1 to 34,comprising baobab.

Embodiment 36: The composition of any one of embodiments 1 to 35,comprising cordyceps.

Embodiment 37: The composition of any one of embodiments 1 to 36,comprising damiana.

Embodiment 38: The composition of any one of embodiments 1 to 37,comprising guarana.

Embodiment 39: The composition of any one of embodiments 1 to 38,comprising guarana, honey, and ashwagandha.

Embodiment 40: The composition of any one of embodiments 1 to 39,comprising maca.

Embodiment 41: The composition of any one of embodiments 1 to 40,comprising caffeine.

Embodiment 42: The composition of any one of embodiments 1 to 41,comprising theacrine.

Embodiment 43: The composition of any one of embodiments 1 to 42,comprising caffeine and theacrine.

Embodiment 44: The composition of any one of embodiments 1 to 43,comprising taurine, theanine, phenylalanine, tyrosine, tryptophan, or acombination thereof.

Embodiment 45: The composition of any one of embodiments 1 to 44,comprising taurine and caffeine.

Embodiment 46: The composition of any one of embodiments 1 to 45,comprising taurine, caffeine, and guarana.

Embodiment 47: The composition of any one of embodiments 1 to 46,comprising taurine, maca, and cordyceps.

Embodiment 48: The composition of any one of embodiments 1 to 47,comprising theanine and caffeine.

Embodiment 49: The composition of any one of embodiments 1 to 48,comprising vitamin B6, vitamin B12, vitamin E, vitamin C, or acombination thereof.

Embodiment 50: The composition of any one of embodiments 1 to 49,comprising vitamin B6, caffeine, and theanine.

Embodiment 51: The composition of any one of embodiments 1 to 50,comprising vitamin B6, vitamin B12, and taurine.

Embodiment 52: The composition of any one of embodiments 1 to 51,comprising vitamin B6, vitamin B12, ginseng, and theanine.

Embodiment 53: The composition of any one of embodiments 1 to 52,comprising vitamin C, baobab, and chlorophyll.

Embodiment 54: The composition of any one of embodiments 1 to 53,comprising nicotine and ginseng.

Embodiment 55: The composition of any one of embodiments 1 to 54,comprising nicotine and caffeine.

Embodiment 56: The composition of any one of embodiments 1 to 55,comprising nicotine and guarana.

Embodiment 57: The composition of any one of embodiments 1 to 56,comprising cannabidiol (CBD).

Embodiment 58: The composition of any one of embodiments 1 to 57,comprising CBD, cocoa, and damiana.

Embodiment 59: The composition of any one of embodiments 1 to 58,comprising an active ingredient having a bitter taste, and a tastemodifier which masks or blocks the perception of the bitter taste.

Embodiment 60: The composition of any one of embodiments 1 to 59,comprising caffeine and gamma-aminobutyric acid (GABA).

Embodiment 61: The composition of any one of embodiments 1 to 60,wherein the total amount of active ingredients is from 0.001% to about30%.

Embodiment 62: A composition comprising: microcrystalline cellulose inan amount of from about 20% to about 40% by weight, based on the totalweight of the composition; at least one active ingredient comprising oneor more botanical materials, stimulants, amino acids, vitamins, or acombination thereof; sodium chloride; xylitol; sucralose;hydroxypropylcellulose, sodium alginate; sodium bicarbonate; propyleneglycol; and a flavoring agent; wherein the composition has a moisturecontent of at least about 40% by weight, based on the total weight ofthe composition.

Embodiment 63: A composition configured to deliver an active ingredientto a user through contact with moisture in the mouth of the user, thecomposition comprising: a filler in an amount of at least 20% by weight,based on the total weight of the composition; at least one activeingredient comprising one or more botanical materials, stimulants, aminoacids, vitamins, antioxidants, cannabinoids, pharmaceutical agents, or acombination thereof; a salt; and at least one sweetener; wherein theproduct composition has a moisture content of at least about 40% byweight, based on the total weight of the composition.

Embodiment 64: The composition of any one of embodiments 1 to 63,further comprising a nicotine component.

Embodiment 65: A method for modifying the flavor profile of an activeingredient in a composition, the composition comprising a filler in anamount of at least 20% by weight, based on the total weight of thecomposition; at least one active ingredient comprising one or morebotanical materials, stimulants, amino acids, vitamins, antioxidants,cannabinoids, pharmaceutical agents, or a combination thereof; a salt;and at least one sweetener; wherein the product composition has amoisture content of at least about 40% by weight, based on the totalweight of the composition; the method comprising providing a tastemodifier in the product composition in an amount effective to mask ormodify a taste sensation in the mouth of the user of the composition.

Embodiment 66: The method of embodiment 65, wherein the taste modifieris selected from the group consisting of an analgesic or anestheticherb, spice, or flavor which produces a perceived cooling or warmingeffect, gamma-aminobutyric acid, capsaicin, and adenosine monophosphate.

Embodiment 67: The method of any one of embodiments 65 to 66, whereinthe taste sensation is bitterness, sweetness, saltiness, or sourness.

Embodiment 68: The method of any one of embodiments 65 to 67, whereinthe taste sensation is bitterness.

Embodiment 69: The method of any one of embodiments 65 to 68, whereinthe taste modifier is capsaicin.

Embodiment 70: A method of preparing a composition comprising a fillerin an amount of at least 20% by weight, based on the total weight of thecomposition; at least one active ingredient comprising one or morebotanical materials, stimulants, amino acids, vitamins, antioxidants,cannabinoids, pharmaceutical agents, or a combination thereof; a salt;and at least one sweetener; wherein the product composition has amoisture content of at least about 40% by weight, based on the totalweight of the composition; the method comprising mixing a filler, atleast one active ingredient, and a salt to form a first mixture; andadding water to the first mixture to form the composition.

Embodiment 71: The method of any one of embodiments 65 to 70, whereinthe composition further comprises a nicotine component.

Embodiment 72: The method of any one of embodiments 65 to 71, furthercomprising adding one or more binders to the first mixture. The methodof the preceding embodiment, further comprising adding a buffer, one ormore sweeteners, a humectant, a flavoring, or a combination thereof, tothe first mixture.

Embodiment 73: The method of any one of embodiments 65 to 72 furthercomprising adding additional water to the composition.

Embodiment 74: The method of any one of embodiments 65 to 73, furthercomprising enclosing the composition in a pouch to form a pouchedproduct.

Embodiment 75: The method of any one of embodiments 65 to 74, furthercomprising adding additional water to the pouched product.

Embodiment 76: A composition prepared by the method of any one ofembodiments 65 to 75.

Embodiments 77: A pouched composition comprising a pouch, and acomposition contained within the pouch, the composition comprising: afiller in an amount of at least 20% by weight, based on the total weightof the composition; theanine, gamma-aminobutyric acid, and optionally,lemon balm extract; a salt; and at least one sweetener; wherein thecomposition has a moisture content of from about 30 to about 40% byweight, based on the total weight of the composition.

These and other features, aspects, and advantages of the disclosure willbe apparent from a reading of the following detailed descriptiontogether with the accompanying drawings, which are briefly describedbelow. The invention includes any combination of two, three, four, ormore of the above-noted embodiments as well as combinations of any two,three, four, or more features or elements set forth in this disclosure,regardless of whether such features or elements are expressly combinedin a specific embodiment description herein. This disclosure is intendedto be read holistically such that any separable features or elements ofthe disclosed invention, in any of its various aspects and embodiments,should be viewed as intended to be combinable unless the context clearlydictates otherwise.

BRIEF DESCRIPTION OF THE DRAWINGS

Having thus described aspects of the disclosure in the foregoing generalterms, reference will now be made to the accompanying drawings, whichare not necessarily drawn to scale. The drawings are exemplary only, andshould not be construed as limiting the disclosure.

FIG. 1 is a perspective view of a pouched product embodiment, takenacross the width of the product, showing an outer pouch filled with acomposition of the present disclosure.

DETAILED DESCRIPTION

The present disclosure provides products configured for oral use, theproducts including a filler in an amount of at least 20% by weight,based on the total weight of the composition, and an active ingredientincluding one or more botanical materials, stimulants, amino acids,vitamins, antioxidants, nicotine components, cannabinoids,pharmaceutical agents, or a combination thereof. The product compositionfurther includes a salt and at least one sweetener. The productcomposition has a moisture content of at least about 40% by weight,based on the total weight of the composition.

The present disclosure will now be described more fully hereinafter withreference to example embodiments thereof. These example embodiments aredescribed so that this disclosure will be thorough and complete, andwill fully convey the scope of the disclosure to those skilled in theart. Indeed, the disclosure may be embodied in many different forms andshould not be construed as limited to the embodiments set forth herein;rather, these embodiments are provided so that this disclosure willsatisfy applicable legal requirements. As used in this specification andthe claims, the singular forms “a,” “an,” and “the” include pluralreferents unless the context clearly dictates otherwise. Reference to“dry weight percent” or “dry weight basis” refers to weight on the basisof dry ingredients (i.e., all ingredients except water). Reference to“wet weight” refers to the weight of the composition including water.Unless otherwise indicated, reference to “weight percent” of acomposition reflects the total wet weight of the composition (i.e.,including water).

The products as described herein comprise a filler, at least one activeingredient, a salt and at least one sweetener. The relative amounts ofthe various components within the composition may vary, and typicallyare selected so as to provide the desired sensory and performancecharacteristics to the oral product. The example individual componentsof the composition are described herein below.

Filler

Compositions as described herein include at least one filler. Suchfillers may fulfill multiple functions, such as enhancing certainorganoleptic properties such as texture and mouthfeel, enhancingcohesiveness or compressibility of the product, and the like. Generally,the fillers are porous particulate materials and are cellulose-based.For example, suitable fillers are any non-tobacco plant material orderivative thereof, including cellulose materials derived from suchsources. Examples of cellulosic non-tobacco plant material includecereal grains (e.g., maize, oat, barley, rye, buckwheat, and the like),sugar beet (e.g., FIBREX® brand filler available from InternationalFiber Corporation), bran fiber, and mixtures thereof. Non-limitingexamples of derivatives of non-tobacco plant material include starches(e.g., from potato, wheat, rice, corn), natural cellulose, and modifiedcellulosic materials. Additional examples of potential fillers includemaltodextrin, dextrose, calcium carbonate, calcium phosphate, lactose,mannitol, xylitol, and sorbitol. Combinations of fillers can also beused.

“Starch” as used herein may refer to pure starch from any source,modified starch, or starch derivatives. Starch is present, typically ingranular form, in almost all green plants and in various types of planttissues and organs (e.g., seeds, leaves, rhizomes, roots, tubers,shoots, fruits, grains, and stems). Starch can vary in composition, aswell as in granular shape and size. Often, starch from different sourceshas different chemical and physical characteristics. A specific starchcan be selected for inclusion in the composition based on the ability ofthe starch material to impart a specific organoleptic property tocomposition. Starches derived from various sources can be used. Forexample, major sources of starch include cereal grains (e.g., rice,wheat, and maize) and root vegetables (e.g., potatoes and cassava).Other examples of sources of starch include acorns, arrowroot,arracacha, bananas, barley, beans (e.g., favas, lentils, mung beans,peas, chickpeas), breadfruit, buckwheat, canna, chestnuts, colacasia,katakuri, kudzu, malanga, millet, oats, oca, Polynesian arrowroot, sago,sorghum, sweet potato, quinoa, rye, tapioca, taro, tobacco, waterchestnuts, and yams. Certain starches are modified starches. A modifiedstarch has undergone one or more structural modifications, oftendesigned to alter its high heat properties. Some starches have beendeveloped by genetic modifications, and are considered to be“genetically modified” starches. Other starches are obtained andsubsequently modified by chemical, enzymatic, or physical means. Forexample, modified starches can be starches that have been subjected tochemical reactions, such as esterification, etherification, oxidation,depolymerization (thinning) by acid catalysis or oxidation in thepresence of base, bleaching, transglycosylation and depolymerization(e.g., dextrinization in the presence of a catalyst), cross-linking,acetylation, hydroxypropylation, and/or partial hydrolysis. Enzymatictreatment includes subjecting native starches to enzyme isolates orconcentrates, microbial enzymes, and/or enzymes native to plantmaterials, e.g., amylase present in corn kernels to modify corn starch.Other starches are modified by heat treatments, such aspregelatinization, dextrinization, and/or cold water swelling processes.Certain modified starches include monostarch phosphate, distarchglycerol, distarch phosphate esterified with sodium trimetaphosphate,phosphate distarch phosphate, acetylated distarch phosphate, starchacetate esterified with acetic anhydride, starch acetate esterified withvinyl acetate, acetylated distarch adipate, acetylated di starchglycerol, hydroxypropyl starch, hydroxypropyl di starch glycerol, andstarch sodium octenyl succinate.

In some embodiments, the filler is a cellulose material or a cellulosederivative. One particularly suitable filler for use in the productsdescribed herein is microcrystalline cellulose (“MCC”). The MCC may besynthetic or semi-synthetic, or it may be obtained entirely from naturalcelluloses. The MCC may be selected from the group consisting of AVICEL®grades PH-100, PH-102, PH-103, PH-105, PH-112, PH-113, PH-200, PH-300,PH-302, VIVACEL® grades 101, 102, 12, 20 and EMOCEL® grades 50M and 90M,and the like, and mixtures thereof In one embodiment, the compositioncomprises MCC as the filler. The quantity of MCC present in thecomposition as described herein may vary according to the desiredproperties.

The amount of filler can vary, but is typically greater than about 20%,and up to about 75% of the composition by weight, based on the totalweight of the composition. A typical range of filler (e.g., MCC) withinthe composition can be from about 20 to about 75% by total weight of thecomposition, for example, from about 20, about 25, or about 30, to about35, about 40, about 45, or about 50% by weight (e.g., about 20 to about50%, or about 25 to about 45% by weight). In certain embodiments, theamount of filler is at least about 20% by weight, such as at least about25%, or at least about 30%, or at least about 35%, or at least about40%, based on the total weight of the composition.

Active Ingredient

The composition as disclosed herein includes one or more activeingredients. As used herein, an “active ingredient” refers to one ormore substances belonging to any of the following categories: API(active pharmaceutical substances), food additives, natural medicaments,and naturally occurring substances that can have an effect on humans.Example active ingredients include any ingredient known to impact one ormore biological functions within the body, such as ingredients thatfurnish pharmacological activity or other direct effect in thediagnosis, cure, mitigation, treatment, or prevention of disease, orwhich affect the structure or any function of the body of humans (e.g.,provide a stimulating action on the central nervous system, have anenergizing effect, an antipyretic or analgesic action, or an otherwiseuseful effect on the body). In some embodiments, the active ingredientmay be of the type generally referred to as dietary supplements,nutraceuticals, “phytochemicals” or “functional foods”. These types ofadditives are sometimes defined in the art as encompassing substancestypically available from naturally-occurring sources (e.g., botanicalmaterials) that provide one or more advantageous biological effects(e.g., health promotion, disease prevention, or other medicinalproperties), but are not classified or regulated as drugs.

Non-limiting examples of active ingredients include those falling in thecategories of botanical ingredients (e.g., hemp, lavender, peppermint,eucalyptus, rooibos, fennel, cloves, chamomile, basil, rosemary, clove,citrus, ginger, cannabis, ginseng, maca, and tisanes), stimulants (e.g.,caffeine or guarana), amino acids (e.g., taurine, theanine,phenylalanine, tyrosine, and tryptophan), vitamins (e.g., B6, B12, andC), antioxidants, nicotine components, pharmaceutical ingredients (e.g.,nutraceutical and medicinal ingredients), cannabinoids (e.g.,tetrahydrocannabinol (THC) or cannabidiol (CBD)) and/or melatonin. Eachof these categories is further described herein below. The particularchoice of active ingredients will vary depending upon the desiredflavor, texture, and desired characteristics of the particular product.

The particular percentages of active ingredients present will varydepending upon the desired characteristics of the particular product.Typically, an active ingredient or combination thereof is present in atotal concentration of at least about 0.001% by weight of thecomposition, such as in a range from about 0.001% to about 30%. In someembodiments, the active ingredient or combination of active ingredientsis present in a concentration from about 0.1% w/w to about 10% byweight, such as, e.g., from about 0.5% w/w to about 20%, from about 1%to about 15%, from about 1% to about 10%, or from about 1% to about 5%by weight, based on the total weight of the composition. In someembodiments, the active ingredient or combination of active ingredientsis present in a concentration of from about 0.001%, about 0.01%, about0.1% , or about 1%, up to about 30% by weight, such as, e.g., from about0.001%, about 0.002%, about 0.003%, about 0.004%, about 0.005%, about0.006%, about 0.007%, about 0.008%, about 0.009%, about 0.01%, about0.02%, about 0.03%, about 0.04%, about 0.05%, about 0.06%, about 0.07%,about 0.08%, about 0.09%, about 0.1%, about 0.2%, about 0.3%, about0.4%, about 0.5% about 0.6%, about 0.7%, about 0.8%, or about 0.9%, toabout 1%, about 2%, about 3%, about 4%, about 5%, about 6%, about 7%,about 8%, about 9%, about 10%, about 11%, about 12%, about 13%, about14%, about 15%, about 16%, about 17%, about 18%, about 19%, about 20%,about 21%, about 22%, about 23%, about 24%, about 25%, about 26%, about27%, about 28%, about 29%, or about 30% by weight, based on the totalweight of the composition. Further suitable ranges for specific activeingredients are provided herein below.

Botanical

In some embodiments, the active ingredient comprises a botanicalingredient. As used herein, the term “botanical ingredient” or“botanical” refers to any plant material or fungal-derived material,including plant material in its natural form and plant material derivedfrom natural plant materials, such as extracts or isolates from plantmaterials or treated plant materials (e.g., plant materials subjected toheat treatment, fermentation, bleaching, or other treatment processescapable of altering the physical and/or chemical nature of thematerial). For the purposes of the present disclosure, a “botanical”includes, but is not limited to, “herbal materials,” which refer toseed-producing plants that do not develop persistent woody tissue andare often valued for their medicinal or sensory characteristics (e.g.,teas or tisanes). Reference to botanical material as “non-tobacco” isintended to exclude tobacco materials (i.e., does not include anyNicotiana species).

When present, a botanical is typically at a concentration of from about0.01% w/w to about 20% by weight, such as, e.g., from about 0.01% w/w,about 0.05%, about 0.1%, or about 0.5%, to about 1%, about 2%, about 3%,about 4%, about 5%, about 6%, about 7%, about 8%, about 9%, or about10%, about 11%, about 12%, about 13%, about 14%, about 15%, about 16%,about 17%, about 18%, about 19%, or about 20% by weight, based on thetotal weight of the composition.

The botanical materials useful in the present disclosure may comprise,without limitation, any of the compounds and sources set forth herein,including mixtures thereof. Certain botanical materials of this type aresometimes referred to as dietary supplements, nutraceuticals,“phytochemicals” or “functional foods.” Certain botanicals, as the plantmaterial or an extract thereof, have found use in traditional herbalmedicine, and are described further herein. Non-limiting examples ofbotanicals or botanical-derived materials include hemp, eucalyptus,rooibos, fennel, citrus, cloves, lavender, lemon balm, peppermint,chamomile, basil, rosemary, ginger, turmeric, green tea, white mulberry,cannabis, cocoa, ashwagandha, baobab, chlorophyll, cordyceps, damiana,ginseng, guarana, cannabis, and maca. In some embodiments, thecomposition comprises green tea, turmeric, and white mulberry. In someembodiments, the composition comprises lemon balm, such as lemon balmextract.

Ashwagandha (Withania somnifera) is a plant in the Solanaceae(nightshade) family. As an herb, Ashwagandha has found use in the IndianAyurvedic system of medicine, where it is also known as “Indian Wintercherry” or “Indian Ginseng.” In some embodiments, the active ingredientcomprises ashwagandha.

Baobab is the common name of a family of deciduous trees of the genusAdansonia. The fruit pulp and seeds of the Baobab are consumed,generally after drying, as a food or nutritional supplement. In someembodiments, the active ingredient comprises baobab.

Chlorophyll is any of several related green pigments found in themesosomes of cyanobacteria, as well as in the chloroplasts of algae andplants. Chlorophyll has been used as a food additive (colorant) and anutritional supplement. Chlorophyll may be provided either from nativeplant materials (e.g., botanicals) or in an extract or dried powderform. In some embodiments, the active ingredient comprises chlorophyll.

Cordyceps is a diverse genus of ascomycete (sac) fungi which areabundant in humid temperate and tropical forests. Members of thecordyceps family are used extensively in traditional Chinese medicine.In some embodiments, the active ingredient comprises cordyceps.

Damiana is a small, woody shrub of the family Passifloraceae. It isnative to southern Texas, Central America, Mexico, South America, andthe Caribbean. Damiana produces small, aromatic flowers, followed byfruits that taste similar to figs. The extract from damiana has beenfound to suppress aromatase activity, including the isolated compoundspinocembrin and acacetin. In some embodiments, the active ingredientcomprises damiana.

Guarana is a climbing plant in the family Sapindaceae, native to theAmazon basin. The seeds from its fruit, which are about the size of acoffee bean, have a high concentration of caffeine and, consequently,stimulant activity. In some embodiments, the active ingredient comprisesguarana. In some embodiments, the active ingredient comprises guarana,honey, and ashwagandha.

Ginseng is the root of plants of the genus Panay, which arecharacterized by the presence of unique steroid saponin phytochemicals(ginsenosides) and gintonin. Ginseng finds use as a dietary supplementin energy drinks or herbal teas, and in traditional medicine. Cultivatedspecies include Korean ginseng (P. ginseng), South China ginseng (P.notoginseng), and American ginseng (P. quinquefolius). American ginsengand Korean ginseng vary in the type and quantity of various ginsenosidespresent. In some embodiments, the active ingredient comprises ginseng.In some embodiments, the ginseng is American ginseng or Korean ginseng.In specific embodiments, the active ingredient comprises Korean ginseng.

Lemon balm (Melissa officinalis) is a mildly lemon-scented herb from thesame family as mint (Lamiaceae). The herb is native to Europe, NorthAfrica, and West Asia. The tea of lemon balm, as well as the essentialoil and the extract, are used in traditional and alternative medicine.In some embodiments, the active ingredient comprises lemon balm extract.

Maca is a plant that grows in central Peru in the high plateaus of theAndes Mountains. It is a relative of the radish, and has an odor similarto butterscotch. Maca has been used in traditional (e.g., Chinese)medicine. In some embodiments, the active ingredient comprises maca.

Stimulants

In some embodiments, the active ingredient comprises one or morestimulants. As used herein, the term “stimulant” refers to a materialthat increases activity of the central nervous system and/or the body,for example, enhancing focus, cognition, vigor, mood, alertness, and thelike. Non-limiting examples of stimulants include caffeine, theacrine,theobromine, and theophylline. Theacrine (1,3,7,9-tetramethyluric acid)is a purine alkaloid which is structurally related to caffeine, andpossesses stimulant, analgesic, and anti-inflammatory effects Presentstimulants may be natural, naturally derived, or wholly synthetic. Forexample, certain botanical materials (guarana, tea, coffee, cocoa, andthe like) may possess a stimulant effect by virtue of the presence ofe.g., caffeine or related alkaloids, and accordingly are “natural”stimulants. By “naturally derived” is meant the stimulant (e.g.,caffeine, theacrine) is in a purified form, outside its natural (e.g.,botanical) matrix. For example, caffeine can be obtained by extractionand purification from botanical sources (e.g., tea). By “whollysynthetic”, it is meant that the stimulant has been obtained by chemicalsynthesis.

When present, a stimulant or combination of stimulants (e.g., caffeine,theacrine, and combinations thereof) is typically at a concentration offrom about 0.1% w/w to about 15% by weight, such as, e.g., from about0.1% w/w, about 0.2%, about 0.3%, about 0.4%, about 0.5% about 0.6%,about 0.7%, about 0.8%, or about 0.9%, to about 1%, about 2%, about 3%,about 4%, about 5%, about 6%, about 7%, about 8%, about 9%, about 10%,about 11%, about 12%, about 13%, about 14%, or about 15% by weight,based on the total weight of the composition.

In some embodiments, the active ingredient comprises caffeine. In someembodiments, the active ingredient comprises theacrine. In someembodiments, the active ingredient comprises a combination of caffeineand theacrine.

Amino Acids

In some embodiments, the active ingredient comprises an amino acid. Asused herein, the term “amino acid” refers to an organic compound thatcontains amine (—NH2) and carboxyl (—COOH) or sulfonic acid (SO₃H)functional groups, along with a side chain (R group), which is specificto each amino acid. Amino acids may be proteinogenic ornon-proteinogenic. By “proteinogenic” is meant that the amino acid isone of the twenty naturally occurring amino acids found in proteins. Theproteinogenic amino acids include alanine, arginine, asparagine,aspartic acid, cysteine, glutamine, glutamic acid, glycine, histidine,isoleucine, leucine, lysine, methionine, phenylalanine, proline, serine,threonine, tryptophan, tyrosine, and valine. By “non-proteinogenic” ismeant that either the amino acid is not found naturally in protein, oris not directly produced by cellular machinery (e.g., is the product ofpost-translational modification). Non-limiting examples ofnon-proteinogenic amino acids include gamma-aminobutyric acid (GABA),taurine (2-aminoethanesulfonic acid), theanine (L-γ-glutamylethylamide),hydroxyproline, and beta-alanine.

When present, an amino acid or combination of amino acids (e.g.,taurine, theanine, GABA, and combinations thereof) is typically at aconcentration of from about 0.01% w/w to about 20% by weight, such as,e.g., from about 0.01, about 0.02, about 0.03, about 0.04, about 0.05,about 0.06, about 0.07, about 0.08, about 0.09, 0.1% w/w, about 0.2%,about 0.3%, about 0.4%, about 0.5% about 0.6%, about 0.7%, about 0.8%,or about 0.9%, to about 1%, about 2%, about 3%, about 4%, about 5%,about 6%, about 7%, about 8%, about 9%, about 10%, about 11%, about 12%,about 13%, about 14%, about 15%, about 16%, about 17%, about 18%, about19%, or about 20% by weight, based on the total weight of thecomposition.

In some embodiments, the amino acid is taurine, theanine, phenylalanine,tyrosine, tryptophan, or a combination thereof. In some embodiments, theamino acid is taurine. In some embodiments, the active ingredientcomprises a combination of taurine and caffeine. In some embodiments,the active ingredient comprises a combination of taurine, caffeine, andguarana. In some embodiments, the active ingredient comprises acombination of taurine, maca, and cordyceps. In some embodiments, theactive ingredient comprises a combination of theanine and caffeine. Insome embodiments, the active ingredient comprises a combination oftheanine and GABA. In some embodiments, the active ingredient comprisestheanine in an amount by weight of from about 5 to about 10%, and GABAin an amount by weight of from about 5 to about 10%, based on the totalweight of the composition. In some embodiments, the active ingredientcomprises a combination of theanine, GABA, and lemon balm.

Vitamins

In some embodiments, the active ingredient comprises a vitamin orcombination of vitamins. As used herein, the term “vitamin” refers to anorganic molecule (or related set of molecules) that is an essentialmicronutrient needed for the proper functioning of metabolism in amammal. There are thirteen vitamins required by human metabolism, whichare: vitamin A (as all-trans-retinol, all-trans-retinyl-esters, as wellas all-trans-beta-carotene and other provitamin A carotenoids), vitaminB1 (thiamine), vitamin B2 (riboflavin), vitamin B3 (niacin), vitamin B5(pantothenic acid), vitamin B6 (pyridoxine), vitamin B7 (biotin),vitamin B9 (folic acid or folate), vitamin B12 (cobalamins), vitamin C(ascorbic acid), vitamin D (calciferols), vitamin E (tocopherols andtocotrienols), and vitamin K (quinones).

When present, a vitamin or combination of vitamins (e.g., vitamin B6,vitamin B12, vitamin E, vitamin C, or a combination thereof) istypically at a concentration of from about 0.01% w/w to about 1% byweight, such as, e.g., from about 0.01%, about 0.02%, about 0.03%, about0.04%, about 0.05%, about 0.06%, about 0.07%, about 0.08%, about 0.09%,or about 0.1% w/w, to about 0.2%, about 0.3%, about 0.4%, about 0.5%about 0.6%, about 0.7%, about 0.8%, about 0.9%, or about 1% by weight,based on the total weight of the composition.

In some embodiments, the vitamin is vitamin B6, vitamin B12, vitamin E,vitamin C, or a combination thereof. In some embodiments, the activeingredient comprises a combination of vitamin B6, caffeine, andtheanine. In some embodiments, the active ingredient comprises vitaminB6, vitamin B12, and taurine. In some embodiments, the active ingredientcomprises a combination of vitamin B6, vitamin B12, ginseng, andtheanine. In some embodiments, the active ingredient comprises acombination of vitamin C, baobab, and chlorophyll.

In certain embodiments, the active ingredient is selected from the groupconsisting of caffeine, taurine, GABA, theanine, vitamin C, lemon balmextract, ginseng, citicoline, sunflower lecithin, and combinationsthereof. For example, the active ingredient can include a combination ofcaffeine, theanine, and optionally ginseng. In another embodiment, theactive ingredient includes a combination of theanine, gamma-aminobutyric acid (GABA), and optionally lemon balm extract. In a furtherembodiment, the active ingredient includes theanine, theanine andtryptophan, or theanine and one or more B vitamins (e.g., vitamin B6 orB12). In a still further embodiment, the active ingredient includes acombination of caffeine, taurine, and vitamin C.

Antioxidants

In some embodiments, the active ingredient comprises one or moreantioxidants. As used herein, the term “antioxidant” refers to asubstance which prevents or suppresses oxidation by terminating freeradical reactions, and may delay or prevent some types of cellulardamage. Antioxidants may be naturally occurring or synthetic. Naturallyoccurring antioxidants include those found in foods and botanicalmaterials. Non-limiting examples of antioxidants include certainbotanical materials, vitamins, polyphenols, and phenol derivatives.

Examples of botanical materials which are associated with antioxidantcharacteristics include without limitation acai berry, alfalfa,allspice, annatto seed, apricot oil, basil, bee balm, wild bergamot,black pepper, blueberries, borage seed oil, bugleweed, cacao, calamusroot, catnip, catuaba, cayenne pepper, chaga mushroom, chervil,cinnamon, dark chocolate, potato peel, grape seed, ginseng, gingkobiloba, Saint John's Wort, saw palmetto, green tea, black tea, blackcohosh, cayenne, chamomile, cloves, cocoa powder, cranberry, dandelion,grapefruit, honeybush, echinacea, garlic, evening primrose, feverfew,ginger, goldenseal, hawthorn, hibiscus flower, jiaogulan, kava,lavender, licorice, marjoram, milk thistle, mints (menthe), oolong tea,beet root, orange, oregano, papaya, pennyroyal, peppermint, red clover,rooibos (red or green), rosehip, rosemary, sage, clary sage, savory,spearmint, spirulina, slippery elm bark, sorghum bran hi-tannin, sorghumgrain hi-tannin, sumac bran, comfrey leaf and root, goji berries, gutukola, thyme, turmeric, uva ursi, valerian, wild yam root, wintergreen,yacon root, yellow dock, Yerba mate, Yerba santa, Bacopa monniera,Withania somnifera, Lion's mane, and Silybum marianum. Such botanicalmaterials may be provided in fresh or dry form, essential oils, or maybe in the form of an extracts. The botanical materials (as well as theirextracts) often include compounds from various classes known to provideantioxidant effects, such as minerals, vitamins, isoflavones,phytoesterols, allyl sulfides, dithiolthiones, isothiocyanates, indoles,lignans, flavonoids, polyphenols, and carotenoids. Examples of compoundsfound in botanical extracts or oils include ascorbic acid, peanutendocarb, resveratrol, sulforaphane, beta-carotene, lycopene, lutein,co-enzyme Q, carnitine, quercetin, kaempferol, and the like. See, e.g.,Santhosh et al., Phytomedicine, 12(2005) 216-220, which is incorporatedherein by reference.

Non-limiting examples of other suitable antioxidants include citricacid, Vitamin E or a derivative thereof, a tocopherol, epicatechol,epigallocatechol, epigallocatechol gallate, erythorbic acid, sodiumerythorbate, 4-hexylresorcinol, theaflavin, theaflavin monogallate A orB, theaflavin digallate, phenolic acids, glycosides, quercitrin,isoquercitrin, hyperoside, polyphenols, catechols, resveratrols,oleuropein, butylated hydroxyanisole (BHA), butylated hydroxytoluene(BHT), tertiary butylhydroquinone (TBHQ), and combinations thereof. Insome embodiments, the antioxidant is Vitamin E or a derivative thereof,a flavonoid, a polyphenol, a carotenoid, or a combination thereof.

When present, an antioxidant is typically at a concentration of fromabout 0.001% w/w to about 10% by weight, such as, e.g., from about0.001%, about 0.005%, about 0.01% w/w, about 0.05%, about 0.1%, or about0.5%, to about 1%, about 2%, about 3%, about 4%, about 5%, about 6%,about 7%, about 8%, about 9%, or about 10%, based on the total weight ofthe composition.

Nicotine Component

In certain embodiments, the active ingredient comprises a nicotinecomponent. By “nicotine component” is meant any suitable form ofnicotine (e.g., free base or salt) for providing oral absorption of atleast a portion of the nicotine present. Typically, the nicotinecomponent is selected from the group consisting of nicotine free baseand a nicotine salt. In some embodiments, the nicotine component isnicotine in its free base form, which easily can be adsorbed in forexample, a microcrystalline cellulose material to form amicrocrystalline cellulose-nicotine carrier complex. See, for example,the discussion of nicotine in free base form in U.S. Pat. Pub. No.2004/0191322 to Hansson, which is incorporated herein by reference.

In some embodiments, at least a portion of the nicotine component can beemployed in the form of a salt. Salts of nicotine can be provided usingthe types of ingredients and techniques set forth in U.S. Pat. No.2,033,909 to Cox et al. and Perfetti, Beitrage Tabakforschung Int., 12:43-54 (1983), which are incorporated herein by reference. Additionally,salts of nicotine are available from sources such as Pfaltz and Bauer,Inc. and K&K Laboratories, Division of ICN Biochemicals, Inc. Typically,the nicotine component is selected from the group consisting of nicotinefree base, a nicotine salt such as hydrochloride, dihydrochloride,monotartrate, bitartrate, sulfate, salicylate, and nicotine zincchloride.

In some embodiments, at least a portion of the nicotine can be in theform of a resin complex of nicotine, where nicotine is bound in anion-exchange resin, such as nicotine polacrilex, which is nicotine boundto, for example, a polymethacrilic acid, such as Amberlite IRP64,Purolite C115HMR, or Doshion P551. See, for example, U.S. Pat. No.3,901,248 to Lichtneckert et al., which is incorporated herein byreference. Another example is a nicotine-polyacrylic carbomer complex,such as with Carbopol 974P. In some embodiments, nicotine may be presentin the form of a nicotine polyacrylic complex.

Typically, the nicotine component (calculated as the free base) whenpresent, is in a concentration of at least about 0.001% by weight of thecomposition, such as in a range from about 0.001% to about 10%. In someembodiments, the nicotine component is present in a concentration fromabout 0.1% w/w to about 10% by weight, such as, e.g., from about 0.1%w/w, about 0.2%, about 0.3%, about 0.4%, about 0.5% about 0.6%, about0.7%, about 0.8%, or about 0.9%, to about 1%, about 2%, about 3%, about4%, about 5%, about 6%, about 7%, about 8%, about 9%, or about 10% byweight, calculated as the free base and based on the total weight of thecomposition. In some embodiments, the nicotine component is present in aconcentration from about 0.1% w/w to about 3% by weight, such as, e.g.,from about 0.1% w/w to about 2.5%, from about 0.1% to about 2.0%, fromabout 0.1% to about 1.5%, or from about 0.1% to about 1% by weight,calculated as the free base and based on the total weight of thecomposition.

In some embodiments, the products or compositions of the disclosure canbe characterized as completely free or substantially free of anynicotine component (e.g., any embodiment as disclosed herein may becompletely or substantially free of any nicotine component). By“substantially free” is meant that no nicotine has been intentionallyadded, beyond trace amounts that may be naturally present in e.g., abotanical material. For example, certain embodiments can becharacterized as having less than 0.001% by weight of nicotine, or lessthan 0.0001%, or even 0% by weight of nicotine, calculated as the freebase.

In some embodiments, the active ingredient comprises a nicotinecomponent (e.g., any product or composition of the disclosure, inaddition to comprising any active ingredient or combination of activeingredients as disclosed herein, may further comprise a nicotinecomponent). In some embodiments, the active ingredient comprises acombination of nicotine and ginseng. In some embodiments, the activeingredient comprises a combination of nicotine and caffeine. In someembodiments, the active ingredient comprises a combination of nicotineand guarana.

Cannabinoids

In some embodiments, the active ingredient comprises one or morecannabinoids. As used herein, the term “cannabinoid” refers to a classof diverse chemical compounds that acts on cannabinoid receptors, alsoknown as the endocannabinoid system, in cells that alterneurotransmitter release in the brain. Ligands for these receptorproteins include the endocannabinoids produced naturally in the body byanimals; phytocannabinoids, found in cannabis; and syntheticcannabinoids, manufactured artificially. Cannabinoids found in cannabisinclude, without limitation: cannabigerol (CBG), cannabichromene (CBC),cannabidiol (CBD), tetrahydrocannabinol (THC), cannabinol (CBN),cannabinodiol (CBDL), cannabicyclol (CBL), cannabivarin (CBV),tetrahydrocannabivarin (THCV), cannabidivarin (CBDV), cannabichromevarin(CBCV), cannabigerovarin (CBGV), cannabigerol monomethyl ether (CBGM),cannabinerolic acid, cannabidiolic acid (CBDA), cannabinol propylvariant (CBNV), cannabitriol (CBO), tetrahydrocannabinolic acid (THCA),and tetrahydrocannabivarinic acid (THCV A). In certain embodiments, thecannabinoid is selected from tetrahydrocannabinol (THC), the primarypsychoactive compound in cannabis, and cannabidiol (CBD) another majorconstituent of the plant, but which is devoid of psychoactivity. All ofthe above compounds can be used in the form of an isolate from plantmaterial or synthetically derived.

Alternatively, the active ingredient can be a cannabimimetic, which is aclass of compounds derived from plants other than cannabis that havebiological effects on the endocannabinoid system similar tocannabinoids. Examples include yangonin, alpha-amyrin or beta-amyrin(also classified as terpenes), cyanidin, curcumin (tumeric), catechin,quercetin, salvinorin A, N-acylethanolamines, and N-alkylamide lipids.

When present, a cannabinoid (e.g., CBD) or cannabimimetic is typicallyin a concentration of at least about 0.1% by weight of the composition,such as in a range from about 0.1% to about 30%, such as, e.g., fromabout 0.1%, about 0.2%, about 0.3%, about 0.4%, about 0.5% about 0.6%,about 0.7%, about 0.8%, or about 0.9%, to about 1%, about 2%, about 3%,about 4%, about 5%, about 6%, about 7%, about 8%, about 9%, about 10%,about 15%, about 20%, or about 30% by weight, based on the total weightof the composition.

Terpenes

Active ingredients suitable for use in the present disclosure can alsobe classified as terpenes, many of which are associated with biologicaleffects, such as calming effects. Terpenes are understood to have thegeneral formula of (C₅E₁₈), and include monoterpenes, sesquiterpenes,and diterpenes. Terpenes can be acyclic, monocyclic or bicyclic instructure. Some terpenes provide an entourage effect when used incombination with cannabinoids or cannabimimetics. Examples includebeta-caryophyllene, linalool, limonene, beta-citronellol, linalylacetate, pinene (alpha or beta), geraniol, carvone, eucalyptol,menthone, iso-menthone, piperitone, myrcene, beta-bourbonene, andgermacrene, which may be used singly or in combination.

Pharmaceutical Ingredients

In some embodiments, the active ingredient comprises a pharmaceuticalingredient. The pharmaceutical ingredient can be any known agent adaptedfor therapeutic, prophylactic, or diagnostic use. These can include, forexample, synthetic organic compounds, proteins and peptides,polysaccharides and other sugars, lipids, inorganic compounds (e.g.,magnesium, selenium, zinc, nitrate), neurotransmitters or precursorsthereof (e.g., serotonin, 5-hydroxy-tryptophan, oxitriptan,acetylcholine, dopamine, melatonin), and nucleic acid sequences, havingtherapeutic, prophylactic, or diagnostic activity. Non-limiting examplesof pharmaceutical ingredients include analgesics and antipyretics (e.g.,acetylsalicylic acid, acetaminophen, 3-(4-isobutylphenyl)propanoicacid), phosphatidylserine, myoinositol, docosahexaenoic acid (DHA,Omega-3), arachidonic acid (AA, Omega-6), S-adenosylmethionine (SAM),beta-hydroxy-beta-methylbutyrate (HMB), citicoline(cytidine-5′-diphosphate-choline), and cotinine.

The amount of pharmaceutical ingredient may vary. For example, whenpresent, a pharmaceutical ingredient is typically at a concentration offrom about 0.001% w/w to about 10% by weight, such as, e.g., from about0.01%, about 0.02%, about 0.03%, about 0.04%, about 0.05%, about 0.06%,about 0.07%, about 0.08%, about 0.09%, about 0.1% w/w, about 0.2%, about0.3%, about 0.4%, about 0.5% about 0.6%, about 0.7%, about 0.8%, about0.9%, or about 1%, to about 2%, about 3%, about 4%, about 5%, about 6%,about 7%, about 8%, about 9%, or about 10% by weight, based on the totalweight of the composition.

Bleached Active Ingredient

In some embodiments, the oral product comprises an active ingredient asdisclosed herein, wherein the active ingredient is characterized asbleached. Such a bleached active ingredient may be desirable e.g., toprevent tooth discoloration during use of the oral product, or so thatany residue remaining in the mouth of the user after use of the productis less visible, and is less likely to cause staining of fibrousmaterials, such as clothing, that may contact the residue. By “bleached”active ingredient is meant an active ingredient (e.g., a botanicalmaterial or derivative thereof), which, in its natural state possesses acolor, and which has been treated to reduce or eliminate the color. By“color” is meant the characteristic of human visual perception describedthrough color categories, with names such as red, blue, yellow (primarycolors) or brown, orange, green, purple, and the like, resulting fromcombinations of primary colors. This perception of color derives fromthe stimulation of cone cells in the human eye by electromagneticradiation in the visible spectrum, associated with objects through thewavelength of the light that is reflected from them. This reflection isgoverned by the object's physical properties such as e.g., absorptionand emission spectra across the electromagnetic spectrum.

Certain active ingredients, by virtue of naturally occurring chemicalcompounds therein which reflect light in the visible range of theelectromagnetic spectrum, impart a color to the active ingredient (e.g.,chlorophyll or pigment decomposition products in certain botanicalmaterials, responsible for green color and brown colors, respectively).Such chemical compounds, or a portion thereof, which are responsible forthe color of the active ingredient, may be chemically altered or removedby various treatments. In some embodiments, the treatment is effectiveto eliminate at least 70% of the chemicals present in the activeingredient having maximum transmission of wavelengths in the visiblerange of the electromagnetic spectrum, based on the weight of thenaturally occurring compounds. For example, such treatment may beeffective to remove 70%, 80%, 90%, 95%, 99%, or even 100% of thenaturally occurring compounds responsible for the visible color of theactive ingredient.

In some embodiments, the treatment for bleaching (i.e., altering orremoving colored chemical compounds from the active ingredient) includesextraction, chemical bleaching, or a combination thereof. Oneparticularly suitable extraction method is supercritical carbon dioxide(CO₂) extraction. Methods of chemical bleaching of e.g., botanicalmaterials, including tobacco, are known, and include as non-limitingexamples, treatment with hydrogen peroxide, ozone, or other oxidizingagents. For example, bleached active ingredients (e.g., a bleachedbotanical or tobacco material) may be produced by various whiteningmethods using various bleaching or oxidizing agents. Example oxidizingagents include peroxides (e.g., hydrogen peroxide), chlorite salts,chlorate salts, perchlorate salts, hypochlorite salts, ozone, ammonia,potassium permanganate, and combinations thereof. Oxidation catalystscan be used. Example oxidation catalysts are titanium dioxide, manganesedioxide, and combinations thereof.

Methods of bleaching known for bleaching tobacco may be applied to thepresent active ingredients. Processes for treating tobacco withbleaching agents are discussed, for example, in U.S. Pat. Nos. 787,611to Daniels, Jr.; 1,086,306 to Oelenheinz; 1,437,095 to Delling;1,757,477 to Rosenhoch; 2,122,421 to Hawkinson; 2,148,147 to Baier;2,170,107 to Baier; 2,274,649 to Baier; 2,770,239 to Prats et al.;3,612,065 to Rosen; 3,851,653 to Rosen; 3,889,689 to Rosen; 3,943,940 toMinami; 3,943,945 to Rosen; 4,143,666 to Rainer; 4,194,514 to Campbell;4,366,823, 4,366,824, and 4,388,933 to Rainer et al.; 4,641,667 toSchmekel et al.; 5,713,376 to Berger; 9,339,058 to Byrd Jr. et al.;9,420,825 to Beeson et al.; and 9,950,858 to Byrd Jr. et al.; as well asin U.S. Pat. App. Pub. Nos. 2012/0067361 to Bjorkholm et al.;2016/0073686 to Crooks; 2017/0020183 to Bjorkholm; and 2017/0112183 toBjorkholm, and in PCT Publ. Appl. Nos. WO1996/031255 to Giolvas andWO2018/083114 to Bjorkholm, all of which are incorporated herein byreference.

In some embodiments, the bleached active agent, or the composition orproduct comprising the bleached active agent, can have an ISO brightnessof at least about 50%, at least about 60%, at least about 65%, at leastabout 70%, at least about 75%, or at least about 80%. In someembodiments, the bleached active agent or the composition or productcomprising the bleached active agent, can have an ISO brightness in therange of about 50% to about 90%, about 55% to about 75%, or about 60% toabout 70%. ISO brightness can be measured according to ISO 3688:1999 orISO 2470-1:2016.

In some embodiments, the bleached active agent can be characterized aslightened in color (e.g., “whitened”) in comparison to an untreatedactive agent. White colors are often defined with reference to theInternational Commission on Illumination's (CIE's) chromaticity diagram.The bleached active agent or the composition or product comprising thebleached active agent, can, in certain embodiments, be characterized ascloser on the chromaticity diagram to pure white than an untreatedactive agent or composition or product comprising an untreated activeagent.

Whiteness values of bleached active ingredients, compositions, andpouched products comprising such ingredients, may be determinedaccording to the Commission Internationale de l′Eclairage (CIE) model,for example, with a hand-held color meter, relative to a control product(See “Precise Color Communication; Color Control from Perception toInstrumentation,” Konica Minolta, 2007;http://konicaminolta.com/instruments/about/network, which isincorporated herein by reference). Discoloration from white may beevaluated by the E313 Whiteness Index according to ASTM method E313,using the formula WI=(3.388Z-3Y, where Y and Z are the CIE tri-stimulusvalues, and measured by a hand-held meter.

Water

The moisture content (e.g., water content) of the composition, prior touse by a consumer of the product, may vary according to the desiredproperties. Typically, the composition, as present within e.g., apouched product, prior to insertion into the mouth of the user, is lessthan about 60% by weight of water, and generally is from about 1 toabout 60% by weight of water, for example, from about 5 to about 55%,about 10 to about 50%, about 20 to about 45%, or about 25 to about 40%water by weight, including water amounts of at least about 5% by weight,at least about 10% by weight, at least about 15% by weight, and at leastabout 20% by weight.

Salts

In some embodiments, the composition comprises a salt (e.g., an alkalimetal salt), typically employed in an amount sufficient to providedesired sensory attributes to the composition. Non-limiting examples ofsuitable salts include sodium chloride, potassium chloride, ammoniumchloride, flour salt, sodium acetate, sodium citrate, and the like. Insome embodiments, the salt is sodium chloride, ammonium chloride, or acombination thereof.

When present, a representative amount of salt is about 0.5% by weight ormore, about 1.0% by weight or more, or about 1.5% by weight or more, butwill typically make up about 10% or less of the total weight of thecomposition, or about 7.5% or less, or about 5% or less (e.g., fromabout 0.5 to about 5% by weight).

Sweeteners

In order to improve the sensory properties of the composition accordingto the disclosure, one or more sweeteners may be added. The sweetenerscan be any sweetener or combination of sweeteners, in natural orartificial form, or as a combination of natural and artificialsweeteners. Examples of natural sweeteners include fructose, sucrose,glucose, maltose, isomaltulose, mannose, galactose, lactose, stevia,honey, and the like. Examples of artificial sweeteners includesucralose, maltodextrin, saccharin, aspartame, acesulfame K, neotame,and the like. In some embodiments, the sweetener comprises one or moresugar alcohols. Sugar alcohols are polyols derived from monosaccharidesor disaccharides that have a partially or fully hydrogenated form. Sugaralcohols have, for example, about 4 to about 20 carbon atoms and includeerythritol, arabitol, ribitol, isomalt, maltitol, dulcitol, iditol,mannitol, xylitol, lactitol, sorbitol, and combinations thereof (e.g.,hydrogenated starch hydrolysates). In some embodiments, the sweetener isxylitol, sucralose, or a combination thereof.

When present, a sweetener or combination of sweeteners may make up fromabout 0.1 to about 20% or more of the of the composition by weight, forexample, from about 0.1 to about 1%, from about 1 to about 5%, fromabout 5 to about 10%, or from about 10 to about 20% by weight, based onthe total weight of the composition. In some embodiments, a combinationof sweeteners is present at a concentration of from about 1% to about 3%by weight of the composition.

Flavoring agents

In some embodiments, the composition comprises a flavoring agent. Asused herein, a “flavoring agent” or “flavorant” is any flavorful oraromatic substance capable of altering the sensory characteristicsassociated with the oral product. Examples of sensory characteristicsthat can be modified by the flavoring agent include taste, mouthfeel,moistness, coolness/heat, and/or fragrance/aroma. Flavoring agents maybe natural or synthetic, and the character of the flavors impartedthereby may be described, without limitation, as fresh, sweet, herbal,confectionary, floral, fruity, or spicy. Specific types of flavorsinclude, but are not limited to, vanilla, coffee, chocolate/cocoa,cream, mint, spearmint, menthol, peppermint, wintergreen, eucalyptus,lavender, cardamom, nutmeg, cinnamon, clove, cascarilla, sandalwood,honey, jasmine, ginger, anise, sage, licorice, lemon, orange, apple,peach, lime, cherry, strawberry, trigeminal sensates, terpenes and anycombinations thereof. See also, Leffingwell et al., Tobacco Flavoringfor Smoking Products, R. J. Reynolds Tobacco Company (1972), which isincorporated herein by reference. Flavoring agents also may includecomponents that are considered moistening, cooling or smootheningagents, such as eucalyptus. These flavors may be provided neat (i.e.,alone) or in a composite, and may be employed as concentrates or flavorpackages (e.g., spearmint and menthol, orange and cinnamon; lime,pineapple, and the like). Representative types of components also areset forth in U.S. Pat. No. 5,387,416 to White et al.; U.S. Pat. App.Pub. No. 2005/0244521 to Strickland et al.; and PCT Application Pub. No.WO 05/041699 to Quinter et al., each of which is incorporated herein byreference. In some instances, the flavoring agent may be provided in aspray-dried form or a liquid form.

The amount of flavoring agent utilized in the composition can vary, butis typically up to about 10% by weight, and certain embodiments arecharacterized by a flavoring agent content of at least about 0.1% byweight, such as about 0.5 to about 10%, about 1 to about 5%, or about 2to about 4% weight, based on the total weight of the composition.

Taste Modifiers

In order to improve the organoleptic properties of a composition asdisclosed herein, the composition may include one or more tastemodifying agents (“taste modifiers”) which may serve to mask, alter,block, or improve e.g., the flavor of a composition as described herein.Non-limiting examples of such taste modifiers include analgesic oranesthetic herbs, spices, and flavors which produce a perceived cooling(e.g., menthol, eucalyptus, mint), warming (e.g., cinnamon), or painful(e.g., capsaicin) sensation. Certain taste modifiers fall into more thanone overlapping category.

In some embodiments, the taste modifier modifies one or more of bitter,sweet, salty, or sour tastes. In some embodiments, the taste modifiertargets pain receptors. In some embodiments, the composition comprisesan active ingredient having a bitter taste, and a taste modifier whichmasks or blocks the perception of the bitter taste. In some embodiments,the taste modifier is a substance which targets pain receptors (e.g.,vanilloid receptors) in the user's mouth to mask e.g., a bitter taste ofanother component (e.g., an active ingredient). In some embodiments, thetaste modifier is capsaicin.

In some embodiments, the taste modifier is the amino acid gamma-aminobutyric acid (GABA), referenced herein above with respect to aminoacids. Studies in mice suggest that

GABA may serve function(s) in taste buds in addition to synapticinhibition. See, e.g., Dvoryanchikov et al., J Neurosci. 2011 Apr13;31(15):5782-91. Without wishing to be bound by theory, GABA maysuppress the perception of certain tastes, such as bitterness. In someembodiments, the composition comprises caffeine and GABA.

In some embodiments, the taste modifier is adenosine monophosphate(AMP). AMP is a naturally occurring nucleotide substance which can blockbitter food flavors or enhance sweetness. It does not directly alter thebitter flavor, but may alter human perception of “bitter” by blockingthe associated receptor.

In some embodiments, the taste modifier is lactisole. Lactisole is anantagonist of sweet taste receptors. Temporarily blocking sweetnessreceptors may accentuate e.g., savory notes.

When present, a representative amount of taste modifier is about 0.01%by weight or more, about 0.1% by weight or more, or about 1.0% by weightor more, but will typically make up less than about 10% by weight of thetotal weight of the composition, (e.g., from about 0.01%, about 0.05%,about 0.1%, or about 0.5%, to about 1%, about 5%, or about 10% by weightof the total weight of the composition).

In a still further aspect is provided a method for modifying the flavorprofile of an active ingredient in a composition, the compositioncomprising a filler in an amount of at least 20%, based on the totalweight of the composition; at least one active ingredient comprising oneor more botanical materials, stimulants, amino acids, vitamins,antioxidants, nicotine components, cannabinoids, pharmaceutical agents,or a combination thereof; a salt; and at least one sweetener; whereinthe product composition has a moisture content of at least about 40% byweight, based on the total weight of the composition; wherein the methodcomprises providing a taste modifier in the product composition in anamount effective to mask or modify a taste sensation in the mouth of theuser of the composition. In some embodiments, the taste modifierselected from the group consisting of an analgesic or anesthetic herb,spice, or flavor which produces a perceived cooling or warming effect,gamma-aminobutyric acid, capsaicin, and adenosine monophosphate. In someembodiments, the taste sensation is bitterness, sweetness, saltiness, orsourness. In some embodiments, the taste sensation is bitterness. Insome embodiments, the taste modifier is capsaicin.

Binders

A binder (or combination of binders) may be employed in certainembodiments, in amounts sufficient to provide the desired physicalattributes and physical integrity to the composition, and binders alsooften function as thickening or gelling agents. Typical binders can beorganic or inorganic, or a combination thereof. Representative bindersinclude cellulose derivatives (e.g., cellulose ethers), povidone, sodiumalginate, starch-based binders, pectin, gums, carrageenan, pullulan,zein, and the like, and combinations thereof. In some embodiments, thebinder comprises pectin or carrageenan or combinations thereof.

The amount of binder utilized in the composition can vary based on thebinder and the desired composition properties, but is typically up toabout 30% by weight, and certain embodiments are characterized by abinder content of at least about 0.1% by weight, such as about 0.5 toabout 30% by weight, or about 1 to about 10% by weight, based on thetotal weight of the composition.

In one embodiment, the binder comprises a cellulose derivative. Incertain embodiments, the cellulose derivative is a cellulose ether(including carboxyalkyl ethers), meaning a cellulose polymer with thehydrogen of one or more hydroxyl groups in the cellulose structurereplaced with an alkyl, hydroxyalkyl, or aryl group. Non-limitingexamples of such cellulose derivatives include methylcellulose,hydroxypropylcellulose (“HPC”), hydroxypropylmethylcellulose (“HPMC”),hydroxyethyl cellulose, and carboxymethylcellulose (“CMC”). In oneembodiment, the cellulose derivative is one or more of methylcellulose,HPC, HPMC, hydroxyethyl cellulose, and CMC. In some embodiments, thecellulose derivative is HPC. In one embodiment, the cellulose derivativeis a combination of HPC and HPMC. In some embodiments, the compositioncomprises from about 1 to about 5% by weight of HPC, for example, fromabout 1%, about 2%, or about 3%, to about 4%, or about 5% by weight ofthe composition.

In certain embodiments, the composition includes a gum binder, forexample, a natural gum. As used herein, a natural gum refers topolysaccharide materials of natural origin that have binding properties,and which are also useful as a thickening or gelling agents.Representative natural gums derived from plants, which are typicallywater soluble to some degree, include xanthan gum, guar gum, gum arabic,ghatti gum, gum tragacanth, karaya gum, locust bean gum, gellan gum, andcombinations thereof. When present, natural gum binder materials aretypically present in an amount of up to about 5% by weight, for example,from about 0.1, about 0.2, about 0.3, about 0.4, about 0.5, about 0.6,about 0.7, about 0.8, about 0.9, or about 1%, to about 2, about 3, about4, or about 5% by weight, based on the total weight of the composition.

In certain embodiments, the composition includes an alginate binder(e.g., sodium or ammonium alginate). In certain embodiments, the bindercomprises a combination of HPC and sodium alginate. When present as abinder, alginate materials are typically present in an amount of up toabout 1% by weight, for example, from about 0.1, about 0.2, about 0.3,about 0.4, or about 0.5, to about 0.6, about 0.7, about 0.8, about 0.9,or about 1%, by weight, based on the total weight of the composition.

Organic Acid

In some embodiments, the composition comprises an organic acid. As usedherein, the term “organic acid” refers to an organic (i.e.,carbon-based) compound that is characterized by acidic properties.Typically, organic acids are relatively weak acids (i.e., they do notdissociate completely in the presence of water), such as carboxylicacids (—CO₂H) or sulfonic acids (—SO₂OH). As used herein, reference toorganic acid means an organic acid that is intentionally added. In thisregard, an organic acid may be intentionally added as a specific mixtureingredient as opposed to merely being inherently present as a componentof another mixture ingredient (e.g., the small amount of organic acidwhich may inherently be present in a mixture ingredient such as atobacco material). In some embodiments, the one or more organic acidsare added neat (i.e., in their free acid, native solid or liquid form)or as a solution in, e.g., water. In some embodiments, the one or moreorganic acids are added in the form of a salt, as described hereinbelow.

Suitable organic acids will typically have a range of lipophilicities(i.e., a polarity giving an appropriate balance of water and organicsolubility). Lipophilicity is conveniently measured in terms of logP,the partition coefficient of a molecule between an aqueous andlipophilic phase, usually water and octanol, respectively. Typically,lipophilicities of organic acids may be between about −2 and about 6.5.In some embodiments, the organic acid may be more soluble in water thanin octanol (i.e., having a negative logP value, such as from about −2 toabout −1). In some embodiments, the organic acid may be about equallysoluble in octanol than in water (i.e., having a logP value of about 0).In some embodiments, the organic acid may be more soluble in octanolthan in water (i.e., having a positive logP value, such as from about 1to about 6.5). In some embodiments, the organic acid has a logP value offrom about 1.5 to about 5.0, e.g., from about 1.5, about 2.0, about 2.5,or about 3.0, to about 3.5, about 4.0, about 4.5, or about 5.0.

In some embodiments, the organic acid is a carboxylic acid or a sulfonicacid. The carboxylic acid or sulfonic acid functional group may beattached to any alkyl, cycloalkyl, heterocycloalkyl, aryl, or heteroarylgroup having, for example, from one to twenty carbon atoms (C₁-C₂₀). Insome embodiments, the organic acid is an alkyl, cycloalkyl,heterocycloalkyl, aryl, or heteroaryl carboxylic or sulfonic acid.

As used herein, “alkyl” refers to any straight chain or branched chainhydrocarbon. The alkyl group may be saturated (i.e., having all sp³carbon atoms), or may be unsaturated (i.e., having at least one site ofunsaturation). As used herein, the term “unsaturated” refers to thepresence of a carbon-carbon, sp² double bond in one or more positionswithin the alkyl group. Unsaturated alkyl groups may be mono- orpolyunsaturated. Representative straight chain alkyl groups include, butare not limited to, methyl, ethyl, n-propyl, n-butyl, n-pentyl, andn-hexyl. Branched chain alkyl groups include, but are not limited to,isopropyl, sec-butyl, isobutyl, tert-butyl, isopentyl, and2-methylbutyl. Representative unsaturated alkyl groups include, but arenot limited to, ethylene or vinyl, allyl, 1-butenyl, 2-butenyl,isobutylenyl, 1-pentenyl, 2-pentenyl, 3-methyl-1-butenyl,2-methyl-2-butenyl, 2,3-dimethyl-2-butenyl, and the like. An alkyl groupcan be unsubstituted or substituted.

“Cycloalkyl” as used herein refers to a carbocyclic group, which may bemono- or bicyclic. Cycloalkyl groups include rings having 3 to 7 carbonatoms as a monocycle or 7 to 12 carbon atoms as a bicycle. Examples ofmonocyclic cycloalkyl groups include cyclopropyl, cyclobutyl,cyclopentyl, cyclohexyl, cycloheptyl, and cyclooctyl. A cycloalkyl groupcan be unsubstituted or substituted, and may include one or more sitesof unsaturation (e.g., cyclopentenyl or cyclohexenyl).

The term “aryl” as used herein refers to a carbocyclic aromatic group.Examples of aryl groups include, but are not limited to, phenyl andnaphthyl. An aryl group can be unsubstituted or substituted.

“Heteroaryl” and “heterocycloalkyl” as used herein refer to an aromaticor non-aromatic ring system, respectively, in which one or more ringatoms is a heteroatom, e.g. nitrogen, oxygen, and sulfur. The heteroarylor heterocycloalkyl group comprises up to 20 carbon atoms and from 1 to3 heteroatoms selected from N, 0, and S. A heteroaryl orheterocycloalkyl may be a monocycle having 3 to 7 ring members (forexample, 2 to 6 carbon atoms and 1 to 3 heteroatoms selected from N, O,and S) or a bicycle having 7 to 10 ring members (for example, 4 to 9carbon atoms and 1 to 3 heteroatoms selected from N, O, and S), forexample: a bicyclo[4,5], [5,5], [5,6], or [6,6] system. Examples ofheteroaryl groups include by way of example and not limitation, pyridyl,thiazolyl, tetrahydrothiophenyl, pyrimidinyl, furanyl, thienyl,pyrrolyl, pyrazolyl, imidazolyl, tetrazolyl, benzofuranyl,thianaphthalenyl, indolyl, indolenyl, quinolinyl, isoquinolinyl,benzimidazolyl, isoxazolyl, pyrazinyl, pyridazinyl, indolizinyl,isoindolyl, 3H-indolyl, 1H-indazolyl, purinyl, 4H-quinolizinyl,phthalazinyl, naphthyridinyl, quinoxalinyl, quinazolinyl, cinnolinyl,pteridinyl, 4aH-carbazolyl, carbazolyl, phenanthridinyl, acridinyl,pyrimidinyl, phenanthrolinyl, phenazinyl, phenothiazinyl, furazanyl,phenoxazinyl, isochromanyl, chromanyl, imidazolidinyl, imidazolinyl,pyrazolidinyl, pyrazolinyl, benzotriazolyl, benzisoxazolyl, andisatinoyl. Examples of heterocycloalkyls include by way of example andnot limitation, dihydroypyridyl, tetrahydropyridyl (piperidyl),tetrahydrothiophenyl, piperidinyl, 4-piperidonyl, pyrrolidinyl,2-pyrrolidonyl, tetrahydrofuranyl, tetrahydropyranyl,bis-tetrahydropyranyl, tetrahydroquinolinyl, tetrahydroisoquinolinyl,decahydroquinolinyl, octahydroisoquinolinyl, piperazinyl, quinuclidinyl,and morpholinyl. Heteroaryl and heterocycloalkyl groups can beunsubstituted or substituted.

“Substituted” as used herein and as applied to any of the above alkyl,aryl, cycloalkyl, heteroaryl, heterocyclyl, means that one or morehydrogen atoms are each independently replaced with a substituent.Typical substituents include, but are not limited to, —Cl, Br, F, alkyl,—OH, —OCH₃, NH₂, —NHCH₃, —N(CH₃)₂, —CN, —NC(═O)CH₃, —C(═O)—, —C(═O)NH₂,and —C(═O)N(CH₃)₂. Wherever a group is described as “optionallysubstituted,” that group can be substituted with one or more of theabove substituents, independently selected for each occasion. In someembodiments, the substituent may be one or more methyl groups or one ormore hydroxyl groups.

In some embodiments, the organic acid is an alkyl carboxylic acid.Non-limiting examples of alkyl carboxylic acids include formic acid,acetic acid, propionic acid, octanoic acid, nonanoic acid, decanoicacid, undecanoic acid, dodecanoic acid, stearic acid, oleic acid,linoleic acid, linolenic acid, and the like. In some embodiments, theorganic acid is an alkyl sulfonic acid. Non-limiting examples of alkylsulfonic acids include propanesulfonic acid and octanesulfonic acid.

In some embodiments, the alkyl carboxylic or sulfonic acid issubstituted with one or more hydroxyl groups. Non-limiting examplesinclude glycolic acid, 4-hydroxybutyric acid, and lactic acid.

In some embodiments, an organic acid may include more than onecarboxylic acid group or more than one sulfonic acid group (e.g., two,three, or more carboxylic acid groups). Non-limiting examples includeoxalic acid, fumaric acid, maleic acid, and glutaric acid. In organicacids containing multiple carboxylic acids (e.g., from two to fourcarboxylic acid groups), one or more of the carboxylic acid groups maybe esterified. Non-limiting examples include succinic acid monoethylester, monomethyl fumarate, monomethyl or dimethyl citrate, and thelike.

In some embodiments, the organic acid may include more than onecarboxylic acid group and one or more hydroxyl groups. Non-limitingexamples of such acids include tartaric acid, citric acid, and the like.

In some embodiments, the organic acid is an aryl carboxylic acid or anaryl sulfonic acid. Non-limiting examples of aryl carboxylic andsulfonic acids include benzoic acid, toluic acids, salicylic acid,benzenesulfonic acid, and p-toluenesulfonic acid.

Additional non-limiting examples of suitable organic acids include2,2-dichloroacetic acid, 2-hydroxyethanesulfonic acid, 2-oxoglutaricacid, 4-acetamidobenzoic acid, 4-aminosalicylic acid, acetic acid,adipic acid, ascorbic acid (L), aspartic acid (L), camphoric acid (+),camphor-10-sulfonic acid (+), capric acid, caproic acid, caprylic acid,cinnamic acid, cyclamic acid, decanoic acid, dodecylsulfuric acid,ethane-1,2-disulfonic acid, ethanesulfonic acid, formic acid, fumaricacid, galactaric acid, gentisic acid, glucoheptonic acid, gluconic acid,glucuronic acid, glutamic acid, glycerophosphoric acid, glycolic acid,hippuric acid, isobutyric acid, lactobionic acid, lauric acid, malonicacid, mandelic acid, methanesulfonic acid, naphthalene-1,5-disulfonicacid, naphthalene-2-sulfonic acid, oleic acid, palmitic acid, pamoicacid, pyroglutamic acid, sebacic acid, stearic acid, and undecylenicacid.

In some embodiments, the one or more organic acids is a single organicacid. In some embodiments, the one or more organic acids is acombination of several acids, such as two, three, or more organic acids.

In some embodiments, the organic acid is citric acid, malic acid,tartaric acid, octanoic acid, benzoic acid, a toluic acid, salicylicacid, or a combination thereof. In some embodiments, the organic acid isbenzoic acid. In some embodiments, the organic acid is citric acid.

In alternative embodiments, a portion, or even all, of the organic acidmay be added in the form of a salt with an alkaline component, which mayinclude, but is not limited to, nicotine. Non-limiting examples ofsuitable salts, e.g., for nicotine, include formate, acetate,propionate, isobutyrate, butyrate, alpha-methylbutyate, isovalerate,beta-methylvalerate, caproate, 2-furoate, phenylacetate, heptanoate,octanoate, nonanoate, oxalate, malonate, glycolate, benzoate, tartrate,levulinate, ascorbate, fumarate, citrate, malate, lactate, aspartate,salicylate, tosylate, succinate, pyruvate, and the like. In someembodiments, the organic acid or a portion thereof may be added in theform of a salt with an alkali metal such as sodium, potassium, and thelike. In organic acids having more than one acidic group (such as a di-or-tri-carboxylic acid), in some instances, one or more of these acidgroups may be in the form of such a salt. Suitable non-limiting examplesinclude monosodium citrate, disodium citrate, and the like. In someembodiments, the organic acid is a salt of citric acid, malic acid,tartaric acid, octanoic acid, benzoic acid, a toluic acid, salicylicacid, or a combination thereof. In some embodiments, the organic acid isa mono or di-ester of a di- or tri-carboxylic acid, respectively, suchas a monomethyl ester of citric acid, malic acid, or tartaric acid, or adimethyl ester of citric acid.

The amount of organic acid present in the mixture may vary. Generally,the mixture comprises from about 0.1 to about 10% by weight of organicacid, present as one or more organic acids, based on the total weight ofthe mixture. In some embodiments, the mixture comprises about 0.1%,about 0.2%, about 0.3%, about 0.4%, about 0.5%, about 0.6%, about 0.7%,about 0.8%, about 0.9%, about 1%, about 2%, about 3%, about 4%, about5%, about 6%, about 7%, about 8%, about 9%, or about 10% organic acid byweight, based on the total weight of the mixture. In some embodiments,the mixture comprises from about 0.1 to about 0.5% by weight of organicacid, for example, about 0.1, about 0.15, about 0.2, about 0.25, about0.3, about 0.35, about 0.4, about 0.45, or about 0.5% by weight, basedon the total weight of the mixture. In some embodiments, the mixturecomprises from about 0.25 to about 0.35% by weight of organic acid, forexample, from about 0.25, about 0.26, about 0.27, about 0.28, about0.29, or about 0.3, to about 0.31, about 0.32, about 0.33, about 0.34,or about 0.35% by weight, based on the total weight of the mixture. Inthe case where a salt of an organic acid is added, the percent by weightis calculated based on the weight of the free acid, not including anycounter-ion which may be present.

Buffering Agents

In certain embodiments, the composition of the present disclosure cancomprise pH adjusters or buffering agents. Examples of pH adjusters andbuffering agents that can be used include, but are not limited to, metalhydroxides (e.g., alkali metal hydroxides such as sodium hydroxide andpotassium hydroxide), and other alkali metal buffers such as metalcarbonates (e.g., potassium carbonate or sodium carbonate), or metalbicarbonates such as sodium bicarbonate, and the like. Non-limitingexamples of suitable buffers include alkali metals acetates, glycinates,phosphates, glycerophosphates, citrates, carbonates, hydrogencarbonates, borates, or mixtures thereof. In some embodiments, thebuffer is sodium bicarbonate.

Where present, the buffering agent is typically present in an amountless than about 5% by weight, based on the weight of the composition,for example, from about 0.1% to about 5%, such as, e.g., from about 0.1%to about 1%, or from about 0.1% to about 0.5% by weight, based on thetotal weight of the composition.

Colorants

A colorant may be employed in amounts sufficient to provide the desiredphysical attributes to the composition. Examples of colorants includevarious dyes and pigments, such as caramel coloring and titaniumdioxide. The amount of colorant utilized in the composition can vary,but when present is typically up to about 3% by weight, such as fromabout 0.1%, about 0.5%, or about 1%, to about 3% by weight, based on thetotal weight of the composition.

Humectants

In certain embodiments, one or more humectants may be employed in thecomposition. Examples of humectants include, but are not limited to,glycerin, propylene glycol, and the like. Where included, the humectantis typically provided in an amount sufficient to provide desiredmoisture attributes to the composition. Further, in some instances, thehumectant may impart desirable flow characteristics to the compositionfor depositing in a mold. In some embodiments, the humectant ispropylene glycol.

When present, a humectant will typically make up about 5% or less of theweight of the composition (e.g., from about 0.1 to about 5% by weight),for example, from about 0.1% to about 1% by weight, or about 1% to about5% by weight, based on the total weight of the composition.

Oral Care Additives

In some embodiments, the composition comprises an oral care ingredient(or mixture of such ingredients). Oral care ingredients provide theability to inhibit tooth decay or loss, inhibit gum disease, relievemouth pain, whiten teeth, or otherwise inhibit tooth staining, elicitsalivary stimulation, inhibit breath malodor, freshen breath, or thelike. For example, effective amounts of ingredients such as thyme oil,eucalyptus oil and zinc (e.g., such as the ingredients of formulationscommercially available as ZYTEX® from Discus Dental) can be incorporatedinto the composition. Other examples of ingredients that can beincorporated in desired effective amounts within the present compositioncan include those that are incorporated within the types of oral carecompositions set forth in Takahashi et al., Oral Microbiology andImmunology, 19(1), 61-64 (2004); U.S. Pat. No. 6,083,527 to Thistle; andU.S. Pat. Appl. Pub. Nos. 2006/0210488 to Jakubowski and 2006/02228308to Cummins et al. Other exemplary ingredients of tobaccocontaining-formulation include those contained in formulations marketedas MALTISORB® by Roquette and DENTIZYME® by NatraRx. When present, arepresentative amount of oral care additive is at least about 1%, oftenat least about 3%, and frequently at least about 5% of the total dryweight of the composition. The amount of oral care additive within thecomposition will not typically exceed about 30%, often will not exceedabout 25%, and frequently will not exceed about 20%, of the total dryweight of the composition.

Other Additives

Other additives can be included in the disclosed composition. Forexample, the composition can be processed, blended, formulated,combined, and/or mixed with other materials or ingredients. Theadditives can be artificial, or can be obtained or derived from herbalor biological sources. Examples of further types of additives includethickening or gelling agents (e.g., fish gelatin), emulsifiers,preservatives (e.g., potassium sorbate and the like), disintegrationaids, zinc or magnesium salts selected to be relatively water solublefor compositions with greater water solubility (e.g., magnesium or zincgluconate) or selected to be relatively water insoluble for compositionswith reduced water solubility (e.g., magnesium or zinc oxide), orcombinations thereof. See, for example, those representative components,combination of components, relative amounts of those components, andmanners and methods for employing those components, set forth in U.S.Pat. Nos. 9,237,769 to Mua et al., . 7,861,728 to Holton, Jr. et al.,U.S. Pat. App. Pub. No. 2010/0291245 to Gao et al., and U.S. Pat. App.Pub. No. 2007/0062549 to Holton, Jr. et al., each of which isincorporated herein by reference. Typical inclusion ranges for suchadditional additives can vary depending on the nature and function ofthe additive and the intended effect on the final composition, with anexample range of up to about 10% by weight, based on total weight of thecomposition (e.g., about 0.1 to about 5% by weight).

The aforementioned additives can be employed together (e.g., as additiveformulations) or separately (e.g., individual additive components can beadded at different stages involved in the preparation of the finalcomposition). Furthermore, the aforementioned types of additives may beencapsulated as provided in the final product or composition. Exemplaryencapsulated additives are described, for example, in WO2010/132444 toAtchley, which has been previously incorporated by reference herein.

Tobacco Material

In some embodiments, the composition may include a tobacco material. Thetobacco material can vary in species, type, and form. Generally, thetobacco material is obtained from for a harvested plant of the Nicotianaspecies. Example Nicotiana species include N. tabacum, N.

rustica, N. alata, N. arentsii, N. excelsior, N. forgetiana, N. glauca,N. glutinosa, N. gossei, N. kawakamii, N. knightiana, N. langsdorffi, N.otophora, N. setchelli, N. sylvestris, N. tomentosa, N. tomentosiformis,N. undulata, N. x sanderae, N. africana, N. amplexicaulis, N.benavidesii, N. bonariensis, N. debneyi, N. longiflora, N. maritina, N.megalosiphon, N. occidentalis, N. paniculata, N. plumbaginifolia, N.raimondii, N. rosulata, N. simulans, N. stocktonii, N.

suaveolens, N. umbratica, N. velutina, N. wigandioides, N. acaulis, N.acuminata, N. attenuata, N. benthamiana, N. cavicola, N. clevelandii, N.cordifolia, N. corymbosa, N. fragrans, N. goodspeedii, N. linearis, N.miersii, N. nudicaulis, N. obtusifolia, N. occidentalis subsp.Hersperis, N. pauciflora, N. petunioides, N. quadrivalvis, N. repanda,N. rotundifolia, N. solanifolia, and N. spegazzinii. Variousrepresentative other types of plants from the Nicotiana species are setforth in Goodspeed, The Genus Nicotiana, (Chonica Botanica) (1954); U.S.Pat. Nos. 4,660,577 to Sensabaugh, Jr. et al.; 5,387,416 to White etal., 7,025,066 to Lawson et al.; 7,798,153 to Lawrence, Jr. and8,186,360 to Marshall et al.; each of which is incorporated herein byreference. Descriptions of various types of tobaccos, growing practicesand harvesting practices are set forth in Tobacco Production, Chemistryand Technology, Davis et al. (Eds.) (1999), which is incorporated hereinby reference.

Nicotiana species from which suitable tobacco materials can be obtainedcan be derived using genetic-modification or crossbreeding techniques(e.g., tobacco plants can be genetically engineered or crossbred toincrease or decrease production of components, characteristics orattributes). See, for example, the types of genetic modifications ofplants set forth in U.S. Pat. Nos. 5,539,093 to Fitzmaurice et al.;5,668,295 to Wahab et al.; 5,705,624 to Fitzmaurice et al.; 5,844,119 toWeigl; 6,730,832 to Dominguez et al.; 7,173,170 to Liu et al.; 7,208,659to Colliver et al. and 7,230,160 to Benning et al.; US Patent Appl. Pub.No. 2006/0236434 to Conkling et al.; and PCT WO2008/103935 to Nielsen etal. See, also, the types of tobaccos that are set forth in U.S. Pat.Nos. 4,660,577 to Sensabaugh, Jr. et al.; 5,387,416 to White et al.; and6,730,832 to Dominguez et al., each of which is incorporated herein byreference.

The Nicotiana species can, in some embodiments, be selected for thecontent of various compounds that are present therein. For example,plants can be selected on the basis that those plants produce relativelyhigh quantities of one or more of the compounds desired to be isolatedtherefrom. In certain embodiments, plants of the Nicotiana species(e.g., Galpao commun tobacco) are specifically grown for their abundanceof leaf surface compounds. Tobacco plants can be grown in greenhouses,growth chambers, or outdoors in fields, or grown hydroponically.

Various parts or portions of the plant of the Nicotiana species can beincluded within a composition as disclosed herein. For example,virtually all of the plant (e.g., the whole plant) can be harvested, andemployed as such. Alternatively, various parts or pieces of the plantcan be harvested or separated for further use after harvest. Forexample, the flower, leaves, stem, stalk, roots, seeds, and variouscombinations thereof, can be isolated for further use or treatment. Insome embodiments, the tobacco material comprises tobacco leaf (lamina).The composition disclosed herein can include processed tobacco parts orpieces, cured and aged tobacco in essentially natural lamina and/or stemform, a tobacco extract, extracted tobacco pulp (e.g., using water as asolvent), or a mixture of the foregoing (e.g., a mixture that combinesextracted tobacco pulp with granulated cured and aged natural tobaccolamina).

In certain embodiments, the tobacco material comprises solid tobaccomaterial selected from the group consisting of lamina and stems. Thetobacco that is used for the mixture most preferably includes tobaccolamina, or a tobacco lamina and stem mixture (of which at least aportion is smoke-treated). Portions of the tobaccos within the mixturemay have processed forms, such as processed tobacco stems (e.g.,cut-rolled stems, cut-rolled-expanded stems or cut-puffed stems), orvolume expanded tobacco (e.g., puffed tobacco, such as dry ice expandedtobacco (DIET)). See, for example, the tobacco expansion processes setforth in U.S. Pat. Nos. 4,340,073 to de la Burde et al.; 5,259,403 toGuy et al.; and 5,908,032 to Poindexter, et al.; and 7,556,047 toPoindexter, et al., all of which are incorporated by reference. Inaddition, the d mixture optionally may incorporate tobacco that has beenfermented. See, also, the types of tobacco processing techniques setforth in PCT WO2005/063060 to Atchley et al., which is incorporatedherein by reference.

The tobacco material is typically used in a form that can be describedas particulate (i.e., shredded, ground, granulated, or powder form). Themanner by which the tobacco material is provided in a finely divided orpowder type of form may vary. Preferably, plant parts or pieces arecomminuted, ground or pulverized into a particulate form using equipmentand techniques for grinding, milling, or the like. Most preferably, theplant material is relatively dry in form during grinding or milling,using equipment such as hammer mills, cutter heads, air control mills,or the like. For example, tobacco parts or pieces may be ground ormilled when the moisture content thereof is less than about 15% byweight, or less than about % by weight. Most preferably, the tobaccomaterial is employed in the form of parts or pieces that have an averageparticle size between 1.4 millimeters and 250 microns. In someinstances, the tobacco particles may be sized to pass through a screenmesh to obtain the particle size range required. If desired, airclassification equipment may be used to ensure that small sized tobaccoparticles of the desired sizes, or range of sizes, may be collected. Ifdesired, differently sized pieces of granulated tobacco may be mixedtogether.

The manner by which the tobacco is provided in a finely divided orpowder type of form may vary. Preferably, tobacco parts or pieces arecomminuted, ground or pulverized into a powder type of form usingequipment and techniques for grinding, milling, or the like. Mostpreferably, the tobacco is relatively dry in form during grinding ormilling, using equipment such as hammer mills, cutter heads, air controlmills, or the like. For example, tobacco parts or pieces may be groundor milled when the moisture content thereof is less than about 15% byweight to less than about 5% by weight. For example, the tobacco plantor portion thereof can be separated into individual parts or pieces(e.g., the leaves can be removed from the stems, and/or the stems andleaves can be removed from the stalk). The harvested plant or individualparts or pieces can be further subdivided into parts or pieces (e.g.,the leaves can be shredded, cut, comminuted, pulverized, milled orground into pieces or parts that can be characterized as filler-typepieces, granules, particulates or fine powders). The plant, or partsthereof, can be subjected to external forces or pressure (e.g., by beingpressed or subjected to roll treatment). When carrying out suchprocessing conditions, the plant or portion thereof can have a moisturecontent that approximates its natural moisture content (e.g., itsmoisture content immediately upon harvest), a moisture content achievedby adding moisture to the plant or portion thereof, or a moisturecontent that results from the drying of the plant or portion thereof.For example, powdered, pulverized, ground or milled pieces of plants orportions thereof can have moisture contents of less than about 25% byweight, often less than about 20%, and frequently less than about 15% byweight.

For the preparation of oral products, it is typical for a harvestedplant of the Nicotiana species to be subjected to a curing process. Thetobacco materials incorporated within the mixture for inclusion withinproducts as disclosed herein are those that have been appropriatelycured and/or aged. Descriptions of various types of curing processes forvarious types of tobaccos are set forth in Tobacco Production, Chemistryand Technology, Davis et al. (Eds.) (1999). Examples of techniques andconditions for curing flue-cured tobacco are set forth in Nestor et al.,Beitrage Tabakforsch. Int., 20, 467-475 (2003) and U.S. Pat. No.6,895,974 to Peele, which are incorporated herein by reference.Representative techniques and conditions for air curing tobacco are setforth in U.S. Pat. No. 7,650,892 to Groves et al.; Roton et al.,Beitrage Tabakforsch. Int., 21, 305-320 (2005) and Staaf et al.,Beitrage Tabakforsch. Int., 21, 321-330 (2005), which are incorporatedherein by reference. Certain types of tobaccos can be subjected toalternative types of curing processes, such as fire curing or suncuring.

In certain embodiments, tobacco materials that can be employed includeflue-cured or Virginia (e.g., K326), burley, sun-cured (e.g., IndianKurnool and Oriental tobaccos, including Katerini, Prelip, Komotini,Xanthi and Yambol tobaccos), Maryland, dark, dark-fired, dark air cured(e.g., Madole, Passanda, Cubano, Jatin and Bezuki tobaccos), light aircured (e.g., North Wisconsin and Galpao tobaccos), Indian air cured, RedRussian and Rustica tobaccos, as well as various other rare or specialtytobaccos and various blends of any of the foregoing tobaccos.

The tobacco material may also have a so-called “blended” form. Forexample, the tobacco material may include a mixture of parts or piecesof flue-cured, burley (e.g., Malawi burley tobacco) and Orientaltobaccos (e.g., as tobacco composed of, or derived from, tobacco lamina,or a mixture of tobacco lamina and tobacco stem). For example, arepresentative blend may incorporate about 30 to about 70 parts burleytobacco (e.g., lamina, or lamina and stem), and about 30 to about 70parts flue cured tobacco (e.g., stem, lamina, or lamina and stem) on adry weight basis. Other example tobacco blends incorporate about 75parts flue-cured tobacco, about 15 parts burley tobacco, and about 10parts Oriental tobacco; or about 65 parts flue-cured tobacco, about 25parts burley tobacco, and about 10 parts Oriental tobacco; or about 65parts flue-cured tobacco, about 10 parts burley tobacco, and about 25parts Oriental tobacco; on a dry weight basis. Other example tobaccoblends incorporate about 20 to about 30 parts Oriental tobacco and about70 to about 80 parts flue-cured tobacco on a dry weight basis.

Tobacco materials used in the present disclosure can be subjected to,for example, fermentation, bleaching, and the like. If desired, thetobacco materials can be, for example, irradiated, pasteurized, orotherwise subjected to controlled heat treatment. Such treatmentprocesses are detailed, for example, in U.S. Pat. No. 8,061,362 to Muaet al., which is incorporated herein by reference. In certainembodiments, tobacco materials can be treated with water and an additivecapable of inhibiting reaction of asparagine to form acrylamide uponheating of the tobacco material (e.g., an additive selected from thegroup consisting of lysine, glycine, histidine, alanine, methionine,cysteine, glutamic acid, aspartic acid, proline, phenylalanine, valine,arginine, compositions incorporating di- and trivalent cations,asparaginase, certain non-reducing saccharides, certain reducing agents,phenolic compounds, certain compounds having at least one free thiolgroup or functionality, oxidizing agents, oxidation catalysts, naturalplant extracts (e.g., rosemary extract), and combinations thereof. See,for example, the types of treatment processes described in U.S. Pat.Pub. Nos. 8,434,496, 8,944,072, and 8,991,403 to Chen et al., which areall incorporated herein by reference. In certain embodiments, this typeof treatment is useful where the original tobacco material is subjectedto heat in the processes previously described.

In various embodiments, the tobacco material can be treated to extract asoluble component of the tobacco material therefrom. “Tobacco extract”as used herein refers to the isolated components of a tobacco materialthat are extracted from solid tobacco pulp by a solvent that is broughtinto contact with the tobacco material in an extraction process. Variousextraction techniques of tobacco materials can be used to provide atobacco extract and tobacco solid material. See, for example, theextraction processes described in U.S. Pat. Appl. Pub. No. 2011/0247640to Beeson et al., which is incorporated herein by reference. Otherexample techniques for extracting components of tobacco are described inU.S. Pat. Nos. 4,144,895 to Fiore; 4,150,677 to Osborne, Jr. et al.;4,267,847 to Reid; 4,289,147 to Wildman et al.; 4,351,346 to Brummer etal.; 4,359,059 to Brummer et al.; 4,506,682 to Muller; 4,589,428 toKeritsis; 4,605,016 to Soga et al.; 4,716,911 to Poulose et al.;4,727,889 to Niven, Jr. et al.; 4,887,618 to Bernasek et al.; 4,941,484to Clapp et al.; 4,967,771 to Fagg et al.; 4,986,286 to Roberts et al.;5,005,593 to Fagg et al.; 5,018,540 to Grubbs et al.; 5,060,669 to Whiteet al.; 5,065,775 to Fagg; 5,074,319 to White et al.; 5,099,862 to Whiteet al.; 5,121,757 to White et al.; 5,131,414 to Fagg; 5,131,415 to Munozet al.; 5,148,819 to Fagg; 5,197,494 to Kramer; 5,230,354 to Smith etal.; 5,234,008 to Fagg; 5,243,999 to Smith; 5,301,694 to Raymond et al.;5,318,050 to Gonzalez-Parra et al.; 5,343,879 to Teague; 5,360,022 toNewton; 5,435,325 to Clapp et al.; 5,445,169 to Brinkley et al.;6,131,584 to Lauterbach; 6,298,859 to Kierulff et al.; 6,772,767 to Muaet al.; and 7,337,782 to Thompson, all of which are incorporated byreference herein.

In some embodiments, the type of tobacco material is selected such thatit is initially visually lighter in color than other tobacco materialsto some degree (e.g., whitened or bleached). Tobacco pulp can bewhitened in certain embodiments according to any means known in the art,and as described above in reference to color-eliminated activeingredients.

Typical inclusion ranges for tobacco materials can vary depending on thenature and type of the tobacco material, and the intended effect on thefinal composition, with an example range of up to about 30% by weight(or up to about 20% by weight or up to about 10% by weight or up toabout 5% by weight), based on total weight of the composition (e.g.,about 0.1 to about 15% by weight). In some embodiments, the products ofthe disclosure can be characterized as completely free or substantiallyfree of tobacco material (other than purified nicotine as an activeingredient). For example, certain embodiments can be characterized ashaving less than 1% by weight, or less than 0.5% by weight, or less than0.1% by weight of tobacco material, or 0% by weight of tobacco material.

Preparation of the Composition

The manner by which the various components of the composition (e.g.,filler, water, active ingredient, and the like) are combined may vary.As such, the overall composition with e.g., powdered compositioncomponents may be relatively uniform in nature. The components notedabove, which may be in liquid or dry solid form, can be admixed in apretreatment step prior to mixture with any remaining components of thecomposition, or simply mixed together with all other liquid or dryingredients. The various components of the composition may be contacted,combined, or mixed together using any mixing technique or equipmentknown in the art. Any mixing method that brings the compositioningredients into intimate contact can be used, such as a mixingapparatus featuring an impeller or other structure capable of agitation.Examples of mixing equipment include casing drums, conditioningcylinders or drums, liquid spray apparatus, conical-type blenders,ribbon blenders, mixers available as FKM130, FKM600, FKM1200, FKM2000and FKM3000 from Littleford Day, Inc., Plough Share types of mixercylinders, Hobart mixers, and the like. See also, for example, the typesof methodologies set forth in U.S. Pat. Nos. 4,148,325 to Solomon etal.; 6,510,855 to Korte et al.; and 6,834,654 to Williams, each of whichis incorporated herein by reference. In some embodiments, the componentsforming the composition are prepared such that the mixture thereof maybe used in a starch molding process for forming the composition. Mannersand methods for formulating compositions will be apparent to thoseskilled in the art. See, for example, the types of methodologies setforth in U.S. Pat. Nos. 4,148,325 to Solomon et al.; 6,510,855 to Korteet al.; and 6,834,654 to Williams, 4,725,440 to Ridgway et al., and6,077,524 to Bolder et al., each of which is incorporated herein byreference.

In some embodiments, any one or more component, and the overall oralproduct described herein, can be described as a particulate material. Asused herein, the term “particulate” refers to a material in the form ofa plurality of individual particles, some of which can be in the form ofan agglomerate of multiple particles, wherein the particles have anaverage length to width ratio less than 2:1, such as less than 1.5:1,such as about 1:1. In various embodiments, the particles of aparticulate material can be described as substantially spherical orgranular.

The particle size of a particulate material may be measured by sieveanalysis. As the skilled person will readily appreciate, sieve analysis(otherwise known as a gradation test) is a method used to measure theparticle size distribution of a particulate material. Typically, sieveanalysis involves a nested column of sieves which comprise screens,preferably in the form of wire mesh cloths. A pre-weighed sample may beintroduced into the top or uppermost sieve in the column, which has thelargest screen openings or mesh size (i.e. the largest pore diameter ofthe sieve). Each lower sieve in the column has progressively smallerscreen openings or mesh sizes than the sieve above. Typically, at thebase of the column of sieves is a receiver portion to collect anyparticles having a particle size smaller than the screen opening size ormesh size of the bottom or lowermost sieve in the column (which has thesmallest screen opening or mesh size).

In some embodiments, the column of sieves may be placed on or in amechanical agitator. The agitator causes the vibration of each of thesieves in the column. The mechanical agitator may be activated for apre-determined period of time in order to ensure that all particles arecollected in the correct sieve. In some embodiments, the column ofsieves is agitated for a period of time from 0.5 minutes to 10 minutes,such as from 1 minute to 10 minutes, such as from 1 minute to 5 minutes,such as for approximately 3 minutes. Once the agitation of the sieves inthe column is complete, the material collected on each sieve is weighed.The weight of each sample on each sieve may then be divided by the totalweight in order to obtain a percentage of the mass retained on eachsieve. As the skilled person will readily appreciate, the screen openingsizes or mesh sizes for each sieve in the column used for sieve analysismay be selected based on the granularity or known maximum/minimumparticle sizes of the sample to be analysed. In some embodiments, acolumn of sieves may be used for sieve analysis, wherein the columncomprises from 2 to 20 sieves, such as from 5 to 15 sieves. In someembodiments, a column of sieves may be used for sieve analysis, whereinthe column comprises 10 sieves. In some embodiments, the largest screenopening or mesh sizes of the sieves used for sieve analysis may be 1000μm, such as 500 μm, such as 400 μm, such as 300 μm.

In some embodiments, any material referenced herein (e.g., filler,tobacco material, and the overall oral product) characterized as beingin particulate form may have at least 50% by weight of particles with aparticle size as measured by sieve analysis of no greater than about1000 μm, such as no greater than about 500 μm, such as no greater thanabout 400 μm, such as no greater than about 350 μm, such as no greaterthan about 300 μm. In some embodiments, at least 60% by weight of theparticles of any particulate material referenced herein have a particlesize as measured by sieve analysis of no greater than about 1000 μm,such as no greater than about 500 μm, such as no greater than about 400μm, such as no greater than about 350 μm, such as no greater than about300 μm. In some embodiments, at least 70% by weight of the particles ofany particulate material referenced herein have a particle size asmeasured by sieve analysis of no greater than about 1000 μm, such as nogreater than about 500 μm, such as no greater than about 400 μm, such asno greater than about 350 μm, such as no greater than about 300 μm. Insome embodiments, at least 80% by weight of the particles of anyparticulate material referenced herein have a particle size as measuredby sieve analysis of no greater than about 1000 μm, such as no greaterthan about 500 μm, such as no greater than about 400 μm, such as nogreater than about 350 μm, such as no greater than about 300 μm. In someembodiments, at least 90% by weight of the particles of any particulatematerial referenced herein have a particle size as measured by sieveanalysis of no greater than about 1000 μm, such as no greater than about500 nm, such as no greater than about 400 μm, such as no greater thanabout 350 μm, such as no greater than about 300 μm. In some embodiments,at least 95% by weight of the particles of any particulate materialreferenced herein have a particle size as measured by sieve analysis ofno greater than about 1000 μm, such as no greater than about 500 μm,such as no greater than about 400 μm, such as no greater than about 350μm, such as no greater than about 300 μm. In some embodiments, at least99% by weight of the particles of any particulate material referencedherein have a particle size as measured by sieve analysis of no greaterthan about 1000 μm, such as no greater than about 500 μm, such as nogreater than about 400 μm, such as no greater than about 350 μm, such asno greater than about 300 μm. In some embodiments, approximately 100% byweight of the particles of any particulate material referenced hereinhave a particle size as measured by sieve analysis of no greater thanabout 1000 μm, such as no greater than about 500 μm, such as no greaterthan about 400 μm, such as no greater than about 350 μm, such as nogreater than about 300 μm.

In some embodiments, at least 50% by weight, such as at least 60% byweight, such as at least 70% by weight, such as at least 80% by weight,such as at least 90% by weight, such as at least 95% by weight, such asat least 99% by weight of the particles of any particulate materialreferenced herein have a particle size as measured by sieve analysis offrom about 0.01 μm to about 1000 μm, such as from about 0.05 μm to about750 μm, such as from about 0.1 μm to about 500 μm, such as from about0.25 μm to about 500 μm. In some embodiments, at least 50% by weight,such as at least 60% by weight, such as at least 70% by weight, such asat least 80% by weight, such as at least 90% by weight, such as at least95% by weight, such as at least 99% by weight of the particles of anyparticulate material referenced herein have a particle size as measuredby sieve analysis of from about 10 μm to about 400 μm, such as fromabout 50 μm to about 350 μm, such as from about 100 μm to about 350 μm,such as from about 200 μm to about 300 μm.

In one embodiment is provided a method of preparing a composition asdisclosed herein, the method comprising mixing a filler, at least oneactive ingredient, and a salt to form a first mixture; and adding waterthe first mixture to form the composition. In some embodiments, themethod further comprises adding one or more binders to the firstmixture. In some embodiments, the method further comprises adding abuffer, one or more sweeteners, a humectant, a flavoring, or acombination thereof, to the first mixture. In some embodiments, themethod further comprises adding additional water to the composition.

In another aspect is provided a composition prepared by the method asdisclosed herein.

Configured for Oral Use Provided herein is a product configured for oraluse. The term “configured for oral use” as used herein means that theproduct is provided in a form such that during use, saliva in the mouthof the user causes one or more of the components of the composition(e.g., flavoring agents and/or active ingredients) to pass into themouth of the user. In certain embodiments, the product is adapted todeliver components to a user through mucous membranes in the user'smouth, the user's digestive system, or both, and, in some instances,said component is an active ingredient (including, but not limited to,for example, a stimulant, vitamin, taste modifier, or combinationthereof) that can be absorbed through the mucous membranes in the mouthor absorbed through the digestive tract when the product is used.

Products configured for oral use as described herein may take variousforms, including gels, pastilles, gums, lozenges, powders, and pouches.Gels can be soft or hard. Certain products configured for oral use arein the form of pastilles. As used herein, the term “pastille” refers toa dissolvable oral product made by solidifying a liquid or gelcomposition so that the final product is a somewhat hardened solid gel.The rigidity of the gel is highly variable. Certain products of thedisclosure are in the form of solids. Certain products can exhibit, forexample, one or more of the following characteristics: crispy, granular,chewy, syrupy, pasty, fluffy, smooth, and/or creamy. In certainembodiments, the desired textural property can be selected from thegroup consisting of adhesiveness, cohesiveness, density, dryness,fracturability, graininess, gumminess, hardness, heaviness, moistureabsorption, moisture release, mouthcoating, roughness, slipperiness,smoothness, viscosity, wetness, and combinations thereof.

The products comprising the compositions of the present disclosure maybe dissolvable. As used herein, the terms “dissolve,” “dissolving,” and“dissolvable” refer to compositions having aqueous-soluble componentsthat interact with moisture in the oral cavity and enter into solution,thereby causing gradual consumption of the product. According to oneaspect, the dissolvable product is capable of lasting in the user'smouth for a given period of time until it completely dissolves.Dissolution rates can vary over a wide range, from about 1 minute orless to about 60 minutes. For example, fast release compositionstypically dissolve and/or release the active substance in about 2minutes or less, often about 1 minute or less (e.g., about 50 seconds orless, about 40 seconds or less, about 30 seconds or less, or about 20seconds or less). Dissolution can occur by any means, such as melting,mechanical disruption (e.g., chewing), enzymatic or other chemicaldegradation, or by disruption of the interaction between the componentsof the composition. In some embodiments, the product can be meltable asdiscussed, for example, in US Patent App. Pub. No. 2012/0037175 toCantrell et al. In other embodiments, the products do not dissolveduring the product's residence in the user's mouth.

In one embodiment, the product comprising the composition of the presentdisclosure is in the form of a composition disposed within amoisture-permeable container (e.g., a water-permeable pouch). Suchcompositions in the water-permeable pouch format are typically used byplacing one pouch containing the composition in the mouth of a humansubject/user. Generally, the pouch is placed somewhere in the oralcavity of the user, for example under the lips, in the same way as moistsnuff products are generally used. The pouch preferably is not chewed orswallowed. Exposure to saliva then causes some of the components of thecomposition therein (e.g., flavoring agents and/or active ingredients)to pass through e.g., the water-permeable pouch and provide the userwith flavor and satisfaction, and the user is not required to spit outany portion of the composition. After about 10 minutes to about 60minutes, typically about 15 minutes to about 45 minutes, ofuse/enjoyment, substantial amounts of the composition have been absorbedthrough oral mucosa of the human subject, and the pouch may be removedfrom the mouth of the human subject for disposal.

Accordingly, in certain embodiments, the composition as disclosed hereinand any other components noted above are combined within amoisture-permeable packet or pouch that acts as a container for use ofthe composition to provide a pouched product configured for oral use.Certain embodiments of the disclosure will be described with referenceto FIG. 1 of the accompanying drawings, and these described embodimentsinvolve snus-type products having an outer pouch and containing acomposition as described herein. As explained in greater detail below,such embodiments are provided by way of example only, and the pouchedproducts of the present disclosure can include the composition in otherforms. The composition/construction of such packets or pouches, such asthe container pouch 102 in the embodiment illustrated in FIG. 1, may bevaried. Referring to FIG. 1, there is shown a first embodiment of apouched product 100. The pouched product 100 includes amoisture-permeable container in the form of a pouch 102, which containsa material 104 comprising a composition as described herein.

Suitable packets, pouches or containers of the type used for themanufacture of smokeless tobacco products may be used for the presentpouched embodiments. Examples of such smokeless tobacco products areavailable under the tradenames CatchDry, Ettan, General, Granit,Goteborgs Rape, Grovsnus White, Metropol Kaktus, Mocca Anis, Mocca Mint,Mocca Wintergreen, Kicks, Probe, Prince, Skruf and TreAnkrare. Thecomposition may be contained in pouches and packaged, in a manner andusing the types of components used for the manufacture of conventionalsnus types of products. The pouch provides a liquid-permeable containerof a type that may be considered to be similar in character to themesh-like type of material that is used for the construction of a teabag. Components of the composition readily diffuse through the pouch andinto the mouth of the user.

Non-limiting examples of suitable types of pouches are set forth in, forexample, U.S. Pat. Nos. 5,167,244 to Kjerstad and 8,931,493 to Sebastianet al.; as well as US Patent App. Pub. Nos. 2016/0000140 to Sebastian etal.; 2016/0073689 to Sebastian et al.; 2016/0157515 to Chapman et al.;and 2016/0192703 to Sebastian et al., each of which is incorporatedherein by reference. Pouches can be provided as individual pouches, or aplurality of pouches (e.g., 2, 4, 5, 10, 12, 15, 20, 25 or 30 pouches)can be connected or linked together (e.g., in an end-to-end manner) suchthat a single pouch or individual portion can be readily removed for usefrom a one-piece strand or matrix of pouches.

An example pouch may be manufactured from materials, and in such amanner, such that during use by the user, the pouch undergoes acontrolled dispersion or dissolution. Such pouch materials may have theform of a mesh, screen, perforated paper, permeable fabric, or the like.For example, pouch material manufactured from a mesh-like form of ricepaper, or perforated rice paper, may dissolve in the mouth of the user.As a result, the pouch and composition each may undergo completedispersion within the mouth of the user during normal conditions of use,and hence the pouch and composition both may be ingested by the user.Other examples of pouch materials may be manufactured using waterdispersible film forming materials (e.g., binding agents such asalginates, carboxymethylcellulose, xanthan gum, pullulan, and the like),as well as those materials in combination with materials such as groundcellulosics (e.g., fine particle size wood pulp). Preferred pouchmaterials, though water dispersible or dissolvable, may be designed andmanufactured such that under conditions of normal use, a significantamount of the composition contents permeate through the pouch materialprior to the time that the pouch undergoes loss of its physicalintegrity. If desired, flavoring ingredients, disintegration aids, andother desired components, may be incorporated within, or applied to, thepouch material.

The amount of material contained within each product unit, for example,a pouch, may vary. In some embodiments, the weight of the compositionwithin each pouch is at least about 50 mg, from about 50 mg to about 2grams, from about 100 mg to about 1.5 grams, or from about 200 to about700 mg. In some smaller embodiments, the weight of the compositionwithin each pouch may be from about 100 to about 300 mg. For a largerembodiment, the weight of the material within each pouch may be fromabout 300 mg to about 700 mg. If desired, other components can becontained within each pouch. For example, at least one flavored strip,piece or sheet of flavored water dispersible or water soluble material(e.g., a breath-freshening edible film type of material) may be disposedwithin each pouch along with or without at least one capsule. Suchstrips or sheets may be folded or crumpled in order to be readilyincorporated within the pouch. See, for example, the types of materialsand technologies set forth in U.S. Pat. Nos. 6,887,307 to Scott et al.and 6,923,981 to Leung et al.; and The EFSA Journal (2004) 85, 1-32;which are incorporated herein by reference.

In certain embodiments, one or more active ingredients as describedherein are included in the composition within the pouched product, andone or more further active ingredients are disposed in or on theexternal surface of the product (e.g., on or in the pouch material asdisclosed herein). In some embodiments, separate location of the activeingredients may allow differential release profiles (e.g., one activeingredient may be rapidly available to the mouth and/or digestivesystem, and the other active ingredient may be released more graduallywith product use).

A pouched product as described herein can be packaged within anysuitable inner packaging material and/or outer container, such as thoseutilized for smokeless tobacco products. See, for example, the varioustypes of containers for smokeless types of products that are set forthin U.S. Pat. Nos. 7,014,039 to Henson et al.; 7,537,110 to Kutsch etal.; 7,584,843 to Kutsch et al.; 8,397,945 to Gelardi et al., D592,956to Thiellier; D594,154 to Patel et al.; and D625,178 to Bailey et al.;U.S. Pat. Pub. Nos. 2008/0173317 to Robinson et al.; 2009/0014343 toClark et al.; 2009/0014450 to Bjorkholm; 2009/0250360 to Bellamah etal.; 2009/0266837 to Gelardi et al.; 2009/0223989 to Gelardi;2009/0230003 to Thiellier; 2010/0084424 to Gelardi; and 2010/0133140 toBailey et al; 2010/0264157 to Bailey et al.; and 2011/0168712 to Baileyet al. which are incorporated herein by reference.

In a further aspect is provided a composition configured to deliver anactive ingredient to a user through contact with moisture in the mouth,the composition comprising a filler in an amount of at least 20% byweight, based on the total weight of the composition; at least oneactive ingredient comprising one or more botanical materials,stimulants, amino acids, vitamins, antioxidants, nicotine components,cannabinoids, pharmaceutical agents, or a combination thereof a salt;and at least one sweetener; wherein the product composition has amoisture content of at least about 40% by weight, based on the totalweight of the composition.

Many modifications and other embodiments of the invention will come tomind to one skilled in the art to which this invention pertains havingthe benefit of the teachings presented in the foregoing description.Therefore, it is to be understood that the invention is not to belimited to the specific embodiments disclosed and that modifications andother embodiments are intended to be included within the scope of theappended claims. Although specific terms are employed herein, they areused in a generic and descriptive sense only and not for purposes oflimitation.

EXAMPLES

Aspects of the present invention are more fully illustrated by thefollowing examples, which are set forth to illustrate certain aspects ofthe present invention and are not to be construed as limiting thereof.

Example 1 Pouched Product with Caffeine and Theanine

Samples of pouched products according to embodiments of the presentdisclosure were prepared from a composition comprising caffeine andtheanine as the active ingredients, and microcrystalline cellulose(MCC), water, and additional components as disclosed herein (salt,binder, cellulose derivative, sweeteners, humectant, buffer, andflavoring agent). The composition was prepared by combiningmicrocrystalline cellulose (138.95 g, 28% of the composition by weight),hydroxypropyl cellulose (15 g, 3% of the composition by weight),caffeine (30.2 g, 6% of the composition by weight), theanine (26.95 g,5.4% of the composition by weight), a salt (20 g, 4% of the compositionby weight) and a binder (3.5 g, 0.7% of the composition by weight) toform a mixture of dry ingredients. To the mixture of dry ingredients wasadded water (59.5 g, 11.9% of the composition by weight), buffer (1.3 g,0.26% of the composition by weight), sweeteners (10.3 g, 2.06% of thecomposition by weight), humectant (4.45 g, 0.89% of the composition byweight), and flavoring agent (5.85 g, 1.17% of the composition byweight). Portions of the composition (442.4 mg) were placed into pouchesfor a product weight of 476 mg and additional water (32% by weight) wassprayed onto the product for a final pouch weight of 700 mg. Themoisture content of the pouched product was 48%, and the pH of thecontents was 7.71.

Example 2 Pouched Product with Caffeine, Theanine, and Vitamin B6

Samples of pouched products according to embodiments of the presentdisclosure were prepared according to the procedure of Example 1, butadding vitamin B6 in an amount of 0.2 g (0.04% of the composition byweight). Portions of the composition (442.4 mg) were placed into pouchesand additional water (32% by weight) was added for a final pouch weightof 700 mg. The moisture content of the pouched product was 48%, and thepH of the contents was 7.74.

Example 3 Pouched Pproduct with Caffeine, Theanine, and Vitamin B6

Samples of pouched products according to embodiments of the presentdisclosure were prepared from a composition comprising caffeine,theanine, and vitamin B6 as the active ingredients, and microcrystallinecellulose (MCC), water, and additional components as disclosed herein(salt, binder, cellulose derivative, sweeteners, humectant, buffer,flavoring agent).

The composition was prepared by combining microcrystalline cellulose(273.75 g, 36.5% of the composition by weight), hydroxypropyl cellulose(22.5 g, 3% of the composition by weight), caffeine (45.3 g, 6% of thecomposition by weight), theanine (40.43 g, 5.4% of the composition byweight), a salt (30 g, 4% of the composition by weight) and a binder(5.25 g, 0.7% of the composition by weight) to form a mixture of dryingredients. To the mixture of dry ingredients was added water (60 g, 8%of the composition by weight), buffer (1.95 g, 0.26% of the compositionby weight), vitamin B6 (0.3 g of the hydrochloride salt, 0.04% of thecomposition by weight), sweeteners (15.1 g, 2.01% of the composition byweight), humectant (6.68 g, 0.89% of the composition by weight), andflavoring agent (8.78 g, 1.17% of the composition by weight). Portionsof the composition (442.4 mg) were placed into pouches for a productweight of 476 mg, and additional water (32% by weight) was sprayed ontothe product for a final pouch weight of 700 mg. The moisture content ofthe pouched product was 40%, and the pH of the contents was 7.85.

Example 4 Pouched Product with Caffeine and GABA

Samples of pouched products according to embodiments of the presentdisclosure were prepared from a composition comprising caffeine andgamma-aminobutyric acid (GABA) as the active ingredients,microcrystalline cellulose (MCC), water, and additional components asdisclosed herein (salt, binder, cellulose derivative, sweeteners,humectant, buffer, flavoring agent). The composition was prepared bycombining microcrystalline cellulose (355.8 g, 35.6% of the compositionby weight), caffeine (60.4 g, 6% of the composition by weight), a salt(40 g, 4% of the composition by weight) and a binder (7 g, 0.7% of thecomposition by weight) to form a mixture of dry ingredients. To themixture of dry ingredients was added water (119 g, 11.9% of thecomposition by weight), buffer (2.6 g, 0.26% of the composition byweight), GABA (6.04 g, 0.6% of the composition by weight), sweeteners(20.6 g, 2.06% of the composition by weight), humectant (8.9 g, 0.89% ofthe composition by weight), and flavoring agent (11.7 g, 1.17% of thecomposition by weight). Portions of the composition (442.4 mg) wereplaced into pouches for a product weight of 476 mg, and additional water(32% by weight) was sprayed onto the product for a final pouch weight of700 mg. The moisture content of the pouched product was 48%, and the pHof the contents was 9.2.

Example 5 . Pouched Product with Taurine

Samples of pouched products according to embodiments of the presentdisclosure were prepared from a composition comprising taurine as theactive ingredient, microcrystalline cellulose (MCC), water, andadditional components as disclosed herein (salt, binder, cellulosederivative, sweeteners, humectant, buffer, flavoring agent). Thecomposition was prepared by combining microcrystalline cellulose (281.1g, 28.1% of the composition by weight), hydroxypropyl cellulose (30 g,3% of the composition by weight), taurine (107.8 g, 10.78% of thecomposition by weight), a salt (40 g, 4% of the composition by weight)and a binder (7 g, 0.7% of the composition by weight) to form a mixtureof dry ingredients. To the mixture of dry ingredients was added water(119 g, 11.9% of the composition by weight), buffer (2.6 g, 0.26% of thecomposition by weight), sweeteners (20.6 g, 2.06% of the composition byweight), humectant (8.9 g, 0.89% of the composition by weight), andflavoring agent (1.5% of the composition by weight). Portions of thecomposition (442.4 mg) were placed into pouches for a product weight of476 mg, and additional water (32% by weight) was sprayed onto theproduct for a final pouch weight of 700 mg. The moisture content of thepouched product was 48%, and the pH of the contents was 7.36.

Example 6 Pouched Product with Taurine and Caffeine

Samples of pouched products according to embodiments of the presentdisclosure were prepared from a composition comprising taurine andcaffeine as the active ingredients, microcrystalline cellulose (MCC),water, and additional components as disclosed herein (salt, binder,cellulose derivative, sweeteners, humectant, buffer, flavoring agent).The composition was prepared by combining microcrystalline cellulose(365 g, 36.5% of the composition by weight), taurine (80 g, 8% of thecomposition by weight), caffeine (60.4 g, 6.04% of the composition byweight) a salt (40 g, 4% of the composition by weight) and a binder (7g, 0.7% of the composition by weight) to form a mixture of dryingredients. To the mixture of dry ingredients was added water (80 g, 8%of the composition by weight), buffer (2.6 g, 0.26% of the compositionby weight), sweeteners (20.6 g, 2.06% of the composition by weight),humectant (8.9 g, 0.89% of the composition by weight), and flavoringagent (16 g, 1.6% of the composition by weight). Portions of thecomposition (442.4 mg) were placed into pouches for a product weight of476 mg, and additional water (32% by weight) was sprayed onto theproduct for a final pouch weight of 700 mg. The moisture content of thepouched product was 40%.

Example 7 Pouched Product with Taurine, Guarana, and Caffeine

Samples of pouched products according to embodiments of the presentdisclosure were prepared according to the procedure of Example 6, butadding guarana (10 g, 1% of the composition by weight). Portions of thecomposition (442.4 mg) were placed into pouches for a product weight of476 mg, and additional water (32% by weight) was sprayed onto theproduct for a final pouch weight of 700 mg. The moisture content of thepouched product was 40%.

Example 8 Pouched Product with American Ginseng

Samples of pouched products according to embodiments of the presentdisclosure were prepared from a composition comprising taurine andcaffeine as the active ingredients, microcrystalline cellulose (MCC),water, and additional components as disclosed herein (salt, binder,cellulose derivative, sweeteners, humectant, buffer, flavoring agent).The composition was prepared by combining microcrystalline cellulose(320.55 g, 42.74% of the composition by weight), ginseng root powder(6.3 g, 0.84% of the composition by weight), a salt (17.25 g, 2.3% ofthe composition by weight) and a binder (5.25 g, 0.7% of the compositionby weight) to form a mixture of dry ingredients. To the mixture of dryingredients was added water (33.75 g, 4.5% of the composition byweight), buffer (1.95 g, 0.26% of the composition by weight), sweeteners(15.75 g, 2.06% of the composition by weight), humectant (4.5 g, 0.6% ofthe composition by weight), and flavoring agent (69 g, 9.2% of thecomposition by weight). Portions of the composition (442.4 mg) wereplaced into pouches for a product weight of 476 mg, and additional water(32% by weight) was sprayed onto the product for a final pouch weight of700 mg. The moisture content of the pouched product was 48%.

Example 9 Pouched Product with Korean Ginseng

Samples of pouched products according to embodiments of the presentdisclosure were prepared according to the procedure of Example 8, butusing Korean (Panax) ginseng. Portions of the composition (442.4 mg)were placed into pouches for a product weight of 476 mg, and additionalwater (32% by weight) was sprayed onto the product for a final pouchweight of 700 mg. The moisture content of the pouched product was 48%.

Example 10 Sensory Preference

Samples of embodiments of pouched products according to Examples 8 and 9were evaluated by a six-person, internal expert sensory panel. Eachsample was evaluated for subjective sensory preference. Both productswere deemed acceptable, with the off notes expected from ginseng presentand aligned with expectations. Example 8 was noted as astringent andearthy, with somewhat inconsistent flavor delivery. In contrast, Example9 (Korean ginseng) delivered more complex and consistent flavor, andproduced more mouth action, tingle, and warmth on the tongue. Overall,the panel's unanimous preference was for Example 9 over Example 8(margin of 6 to 0). The sensory data demonstrated that Korean ginsengprovided a composition with a superior sensory experience relative to acomposition containing American ginseng.

Example 11 Pouched Product Containing L-Theanine and GABA

Samples of pouched products according to embodiments of the presentdisclosure were prepared from a composition containing a mixture ofL-theanine and gamma-aminobutyric acid (GABA) as the active ingredient,microcrystalline cellulose (MCC), water and additional components asdisclosed herein (salt, binder, sweeteners, humectant, buffer, andflavoring agent). The ingredients of the composition and theirconcentrations in the composition in weight % are provided in Table 1.The composition was prepared by combining all the dry ingredients with aportion of the water (8% by weight). Portions of the composition wereplaced into pouches, and additional water (32% by weight) was sprayedonto the product for a final pouch weight of ˜700 mg. The moisturecontent of the pouched product was 40%.

TABLE 1 Pouched product ingredients Ingredient Weight % water  40% MCC30-40%  L-theanine 5-10%  GABA 5-10%  sodium chloride 3-5% sodiumalginate 0.5-1%  sweetener 1-3% flavoring agent 1-3% buffer 0.1-0.5%   propylene glycol 0.5-1.5%   

Example 12 Pouched Product Containing L-Theanine, GABA, and Llemon Balm

Samples of pouched products according to embodiments of the presentdisclosure were prepared according to Example 11, but using a mixture ofL-theanine, gamma-aminobutyric acid (GABA) and lemon balm extract as theactive ingredients. The ingredients of the composition and theirconcentrations in the composition in weight % are provided in Table 2.

TABLE 2 Pouched product ingredients Ingredient Weight % water  40% MCC20-40%  L-theanine 3-5% GABA 4-6% lemon balm extract 0.01-15%    sodiumchloride 3-5% sodium alginate 0.5-1%  sweetener 1-3% flavoring agent1-3% buffer 0-0.5%  propylene glycol 0.5-1.5%   

Example 13 Pouched Product Containing Caffeine, Taurine, and Vitamin C

Samples of pouched products according to embodiments of the presentdisclosure were prepared according to Example 11, but using a mixture ofcaffeine, taurine, and Vitamin C. The ingredients of the composition andtheir concentrations in the composition in weight % are provided inTable 3.

TABLE 3 Pouched product ingredients Ingredient Weight % water 40-50% MCC 30-40%  caffeine 3-5% taurine 4-6% Vitamin C 4-6% sodium chloride3-5% sodium alginate 0.5-1%  sweetener 1-3% flavoring agent 1-3% buffer0.1-0.5%    propylene glycol 0.5-1.5%   

Example 14 Pouched Pproduct Containing Caffeine, Theanine, Ginseng, andCiticoline

Samples of pouched products according to embodiments of the presentdisclosure were prepared according to Example 11, but using a mixture ofcaffeine, theanine, ginseng, and citicoline. The ingredients of thecomposition and their concentrations in the composition in weight % areprovided in Table 4.

TABLE 4 Pouched product ingredients Ingredient Weight % water 40-50% MCC 30-40%  caffeine 3-5% theanine 3-5% ginseng 0.4-0.6%    citicoline0.5-1.5%    sodium chloride 3-5% sodium alginate 0.5-1%  sweetener 1-3%flavoring agent 1-3% buffer 0.1-0.5%    propylene glycol 0.5-1.5%   

What is claimed is:
 1. A composition comprising: a filler in an amountof at least 20% by weight, based on the total weight of the composition;at least one active ingredient comprising one or more botanicalmaterials, stimulants, amino acids, vitamins, antioxidants,cannabinoids, pharmaceutical agents, or a combination thereof; a salt;and at least one sweetener; wherein the composition has a moisturecontent of at least about 40% by weight, based on the total weight ofthe composition.
 2. The composition of claim 1, wherein the filler ismicrocrystalline cellulose.
 3. The composition of claim 1, furthercomprising a cellulose derivative.
 4. The composition of claim 1,wherein the salt is sodium chloride, ammonium chloride, or a combinationthereof.
 5. The composition of claim 1, further comprising a tastemodifier.
 6. The composition of claim 5, wherein the taste modifiermodifies one or more of bitter, sweet, salty, or sour tastes.
 7. Thecomposition of claim 5, wherein the taste modifier is selected from thegroup consisting of gamma-aminobutryic acid (GABA), adenosinemonophosphate (AMP), lactisole, a vanilloid receptor agonist, ananalgesic or anesthetic herb, menthol, eucalyptus, mint, and cinnamon.8. The composition of claim 5, wherein the taste modifier is capsaicin.9. The composition of claim 1, wherein the active ingredient is abotanical material.
 10. The composition of claim 9, wherein thebotanical material is Korean ginseng.
 11. The composition of claim 1,wherein the active ingredient is a stimulant.
 12. The composition ofclaim 11, wherein the stimulant is caffeine, theanine, or a combinationthereof.
 13. The composition of claim 12, further comprising a vitamin,an amino acid, or a combination thereof, as an additional activeingredient.
 14. The composition of claim 13, wherein the vitamin is B6,B12, or a combination thereof
 15. The composition of claim 13, whereinthe amino acid is taurine.
 16. The composition of claim 1, furthercomprising an alginate.
 17. The composition of claim 1, wherein theactive ingredient comprises a combination of theanine andgamma-aminobutyric acid.
 18. The composition of claim 17, furthercomprising lemon balm extract.
 19. The composition of claim 1, whereinthe active ingredient comprises a combination of caffeine, taurine, andVitamin C.
 20. The composition of claim 1, wherein the active ingredientcomprises a combination of caffeine, theanine, and ginseng, andoptionally, citicoline.
 21. The composition of claim 1, furthercomprising one or more organic acids.
 22. The composition of claim 21,wherein the one or more organic acids is present in the composition inan amount by weight of from about 0.1 to about 10%, based on the totalweight of the composition.
 23. The composition of claim 21, wherein theone or more organic acids is present in the composition in an amount byweight of from about 0.1 to about 0.5%, based on the total weight of thecomposition.
 24. The composition of claim 21, wherein the one or moreorganic acids is an alkyl carboxylic acid, an aryl carboxylic acid, or acombination of any thereof.
 25. The composition of claim 21, wherein theone or more organic acids is citric acid, malic acid, tartaric acid,octanoic acid, benzoic acid, a toluic acid, salicylic acid, or acombination thereof.
 26. The composition of claim 25, wherein the one ormore organic acids is citric acid.
 27. The composition of claim 1,wherein the salt is sodium chloride, ammonium chloride, or a combinationthereof.
 28. The composition of claim 1, wherein the composition issubstantially free of tobacco.
 29. The composition of claim 1, whereinthe composition is substantially free of nicotine.
 30. The compositionof claim 1, wherein the composition further comprises a nicotinecomponent.
 31. The composition of claim 1, wherein the at least oneactive ingredient is selected from the group consisting of green tea,turmeric, and white mulberry, ashwagandha, baobab, chlorophyll,cordyceps, guarana, ginseng, maca, caffeine, theacrine, taurine,theanine, phenylalanine, tyrosine, tryptophan, vitamin B6, vitamin B12,vitamin E, vitamin C, GABA, vitamin C, lemon balm extract, ginseng,citicoline, sunflower lecithin, cannabinoids, terpenes, and combinationsthereof.
 32. The composition of claim 1, wherein the active ingredientis bleached.
 33. The composition of claim 1, wherein the composition isenclosed in a pouch to form a pouched product.
 34. A pouched compositioncomprising a pouch, and a composition contained within the pouch, thecomposition comprising: a filler in an amount of at least 20% by weight,based on the total weight of the composition; theanine,gamma-aminobutyric acid, and optionally, lemon balm extract; a salt; andat least one sweetener; wherein the composition has a moisture contentof from about 30 to about 40% by weight, based on the total weight ofthe composition.